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Tretinoin 1 mg/g Cream — NDC 21922-0077-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tretinoin 1 mg/g Cream — NDC 21922-077-25 (Billing 21922-0077-25)

by Encube Ethicals, Inc. · 1 TUBE in 1 CARTON / 20 g in 1 TUBE

This is a package of Tretinoin 1 mg/g Cream from Encube Ethicals, Inc., marketed since Feb 2026 and currently FDA-listed; retail pharmacies pay about $0.9196 per g (NADAC).

NDC 21922-0077-25
🏷️ FDA NDC (as labeled) 21922-077-25 billing pads the product segment with a zero
This package
Contains20 g in 1 tube Cost per g$0.9196 NADAC Per package$18.39 / 20 g Pack sizes2 compare ↓
Also priced by: Part D plans $1.79/unit — full pricing hub ↓
Product page 21922-0077-06 Also comes in: 45 g 21922-077-06
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 21922-077-25 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
21922 labeler · 077 product · 25 package
Package marketed since
Feb 13, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 2192207725 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 21922-077-25
Product NDC 21922-077
11-digit billing NDC 21922007725
NCPDP billing unit GM — per gram (weight)
RxCUI 106302, 106303, 198300
UNII 5688UTC01R
Application # ANDA217833
SPL Set ID 5e3fb8ea-234c-4be2-95a7-d139e069cf98
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-13
Route TOPICAL
Dosage form CREAM
Substance TRETINOIN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90050030003710
GCN Seq No 005801
GCN 22881
HICL code 002468
Ingredient (HICL) Tretinoin
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L9
Therapeutic class — intermediate (HIC2) Dermatologic Preparations,Miscellaneous
HIC3 code L9B
Therapeutic class — specific (HIC3) Vitamin A Derivatives
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name TRETINOIN 0.1% CREAM
FDB brand name Tretinoin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005801
  • GCN: 22881
  • GPI-14 (Medi-Span): 90050030003710
  • HICL (First Databank): 002468
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 106302
Why two NDCs? The FDA registers this code as 21922-077-25 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 21922-0077-25. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for topical use in acne, Retinoids for cancer treatment
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TRETINOIN 0.1% CREAM Ingredient Tretinoin
📗 Our plain-language guide HelloPharmacist
  • It depends on the form. Creams, gels and lotions treat acne, and Renova eases fine facial wrinkles. The capsules treat a blood cancer called acute promyelocytic leukemia.
  • Wash the area, pat dry, and apply a thin layer once daily, usually in the evening. Keep it away from your eyes, mouth, nose creases and mucous membranes. More does not work faster...
  • Mild warmth or stinging, redness and peeling are common. If it becomes severe, call your prescriber, who may have you use less or pause. Acne can seem to flare early on, which is n...
  • What side effects should I expect on the skin?
📖 Read our full Tretinoin guide →
1
Nutrient depletion considerations

Tretinoin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Tretinoin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.920 $18.39 / 20 g
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.79 $35.81 / 20 g
NADAC price history (per g) — tap or hover for the price & month
Sep 2026 $0.920 $0.920
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
21922-0077-06 21922-077-06 Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE $0.7701 / g $34.65 2026-02-13 — Active
21922-0077-25 You're viewing this 1 TUBE in 1 CARTON / 20 g in 1 TUBE $0.9196 / g $18.39 2026-02-13 — Active

Per g, this pack runs about 19% above the cheapest pack (NDC 21922-0077-06, $0.7701 vs $0.9196 NADAC).

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 20 g in 1 tube.
What NDC number is used to bill for this package of Tretinoin 1 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tretinoin 1 mg/g 72578-0153-08 Viona 1 tube $0.770 AB Availability likely save 16%
Tretinoin 1 mg/g 00378-8084-20 Mylan 1 tube $0.920 AB Availability likely —
Tretinoin 1 mg/g 00574-2201-20 Padagis 1 tube $0.920 AB Availability likely —
Tretinoin 1 mg/g 16714-0250-01 NORTHSTAR 1 tube $0.920 AB Availability likely —
Tretinoin 1 mg/gthis 21922-0077-25 Encube 1 tube $0.920 AB Availability likely —
Tretinoin 1 mg/g 51672-1395-00 Sun 1 tube $0.920 AB Availability likely —
Tretinoin 1 mg/g 62332-0807-20 Alembic 1 tube $0.920 AB Availability likely —
Retin-A 1 mg/g 00187-5164-20 Bausch 1 tube $0.960 AB FDA listed +4%
Tretinoin 1 mg/g 46708-0807-20 Alembic 1 tube — AB FDA listed —
Tretinoin 1 mg/g 50090-4347-00 A-S 1 tube — AB FDA listed —
Tretinoin Cream 1 mg/g 62032-0417-20 Obagi 1 tube — AB FDA listed —
Tretinoin 1 mg/g 68071-3826-02 NuCare 1 tube — AB FDA listed —
Tretinoin 1 mg/g 68071-3889-02 NuCare 1 tube — AB FDA listed —
Tretinoin 1 mg/g 70518-3233-00 REMEDYREPACK 1 tube — AB FDA listed —
Tretinoin 1 mg/g 70771-1873-02 Zydus 1 tube — AB FDA listed —
Tretinoin 1 mg/g 68682-0513-82 Oceanside 1 tube — — FDA listed —
Retin-A MICRO 1 mg/g 00187-5140-20 Bausch 1 tube — — Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Tretinoin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerEncube Ethicals, Inc.
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA217833 (ANDA)
Labeler code21922
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio77 products on file

More NDCs from Encube Ethicals, Inc. labeler code 21922

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

INDICATIONS AND USAGE Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

⏱️ Dosage and Administration 213 words ▾

DOSAGE AND ADMINISTRATION Tretinoin cream, USP should be applied once a day, before retiring to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment.

Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.

Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen. Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms. Patients treated with tretinoin acne treatment may use cosmetics, but the area to be treated should be cleansed thoroughly before the medication is applied.

(see PRECAUTIONS.)

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

⚠️ Warnings 23 words ▾

WARNINGS Keep out of reach of children. Keep tube tightly closed. Do not expose to heat or store at temperatures above 120°F (49°C).

🤒 Adverse Reactions 123 words ▾

ADVERSE REACTIONS The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered.

Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin cream. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin cream. To date, all adverse effects of tretinoin cream have been reversible upon discontinuance of therapy (see Dosage and Administration).

To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 80 words ▾

Drug Interactions Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with tretinoin. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of tretinoin is begun.

🤰 Pregnancy ~2 min read ▾

Pregnancy Teratogenic Effects Oral tretinoin has been shown to be teratogenic in rats, mice, hamsters, and subhuman primates. It was teratogenic and fetotoxic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (8 times the maximum human systemic dose adjusted for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported.

In the cynomolgus monkey, which metabolically is closer to humans for tretinoin than the other species examined, fetal malformations were reported at doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (83 times the maximum human systemic dose adjusted for total body surface area), although increased skeletal variations were observed at all doses. A dose-related increase in embryolethality and abortion was reported. Similar results have also been reported in pigtail macaques.

Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (8 times the maximum human systemic dose adjusted for total body surface area). Anomalies (humerus: short 13%, bent 6%, os parietale incompletely ossified 14%) have also been reported when 10 mg/kg/day was topically applied.

There are other reports in New Zealand White rabbits administered doses of greater than 0.2 mg/kg/day (3.3 times the maximum human systemic dose adjusted for total body surface area) of an increased incidence of domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species. In contrast, several well-controlled animals studies have shown that dermally applied tretinoin may be fetotoxic, but not overly teratogenic in rats and rabbits at doses of 1.0 and 0.5 mg/kg/day, respectively (8 times the maximum human systemic dose adjusted for total body surface area in both species).

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of tretinoin. Although no definite pattern of teratogenicity and no causal association have been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain).

The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic Effects Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times the maximum human systemic dose adjusted for total body surface area). Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death in rats when administered 2.5 mg/kg/day (20 times the maximum human systemic dose adjusted for total body surface area).

There are, however, no adequate and well-controlled studies in pregnant women. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 17 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.

🧓 Geriatric Use 37 words ▾

Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of tretinoin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.

🆘 Overdosage 45 words ▾

OVERDOSAGE If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

🧬 Clinical Pharmacology 45 words ▾

CLINICAL PHARMACOLOGY Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

📦 How Supplied / Storage and Handling 91 words ▾

HOW SUPPLIED Tretinoin Cream, USP are supplied as: NDC Code Strength Quantity 21922-077-25 0.1% 20 g 21922-077-06 0.1% 45 g 21922-078-25 0.05% 20 g 21922-078-06 0.05% 45 g 21922-079-25 0.025% 20 g 21922-079-06 0.025% 45 g Storage Conditions: Tretinoin Cream, USP 0.1%, 0.05% and 0.025%: store below 80°F. Rx only Manufactured by: Encube Ethicals Pvt. Ltd.

Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc.

200 Meredith Drive, Suite 202, Durham, North Carolina (NC) 27713, United States (USA) Revised: 03/2026

📋 Description 64 words ▾

DESCRIPTION Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Tretinoin Cream, USP contains tretinoin in either of three strengths, 0.1%, 0.05% or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure: structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during the use of tretinoin cream, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution.

Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. Tretinoin acne treatment should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes.

Topical use may induce severe local erythema and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, discontinue use temporarily, or discontinue use altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.

Drug Interactions Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with tretinoin. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of tretinoin is begun.

Carcinogenesis, Mutagenesis, Impairment to Fertility In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively.

These doses are two and four times the maximum human systemic dose, when adjusted for total body surface area. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the maximum human systemic dose, adjusted for total body surface area).

For purposes of comparisons of the animal exposure to systemic human exposure, the maximum human systemic dose is defined as 1 gram of 0.1% tretinoin applied daily to a 50 kg person (0.02 mg tretinoin/kg body weight). Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin.

Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources. The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative. In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (4 times the ma… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 34 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tretinoin is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

Carcinogenesis, Mutagenesis, Impairment to Fertility In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively.

These doses are two and four times the maximum human systemic dose, when adjusted for total body surface area. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the maximum human systemic dose, adjusted for total body surface area).

For purposes of comparisons of the animal exposure to systemic human exposure, the maximum human systemic dose is defined as 1 gram of 0.1% tretinoin applied daily to a 50 kg person (0.02 mg tretinoin/kg body weight). Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin.

Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources. The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative. In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (4 times the maximum human systemic dose adjusted for total body surface area), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day (2 times the maximum human systemic dose adjusted for total body surface area) and above were observed.

A dermal Segment III study with tretinoin has not been performed in any species. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (16 times the human topical dose adjusted for total body surface area).

📄 Patient Package Insert ~3 min read ▾

PATIENT INSTRUCTIONS Tretinoin Cream, USP For Topical Use Only Acne Treatment IMPORTANT Read Directions Carefully Before Using THIS LEAFLET TELLS YOU ABOUT TRETINOIN ACNE TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. THIS PRODUCT IS TO BE USED ONLY ACCORDING TO YOUR DOCTOR’S INSTRUCTIONS, AND IT SHOULD NOT BE APPLIED TO OTHER AREAS OF THE BODY OR TO OTHER GROWTHS OR LESIONS. THE LONG-TERM SAFETY AND EFFECTIVENESS OF THIS PRODUCT IN OTHER DISORDERS HAVE NOT BEEN EVALUATED.

IF YOU HAVE ANY QUESTIONS, BE SURE TO ASK YOUR DOCTOR. WARNINGS Keep out of reach of children. Keep tube tightly closed.

Do not expose to heat or store at temperatures above 120°F (49°C). PRECAUTIONS The effects of the sun on your skin. As you know, overexposure to natural sunlight or the artificial sunlight of a sunlamp can cause sunburn.

Overexposure to the sun over many years may cause premature aging of the skin and even skin cancer. The chance of these effects occurring will vary depending on skin type, the climate and the care taken to avoid overexposure to the sun. Therapy with tretinoin may make your skin more susceptible to sunburn and other adverse effects of the sun, so unprotected exposure to natural or artificial sunlight should be minimized.

Laboratory findings. When laboratory mice are exposed to artificial sunlight, they often develop skin tumors. These sunlight-induced tumors may appear more quickly and in greater number if the mouse is also topically treated with the active ingredient in tretinoin cream, tretinoin.

In some studies, under different conditions, however, when mice treated with tretinoin were exposed to artificial sunlight, the incidence and rate of development of skin tumors was reduced. There is no evidence to date that tretinoin alone will cause the development of skin tumors in either laboratory animals or humans. However, investigations in this area are continuing.

Use caution in the sun. When outside, even on hazy days, areas treated with tretinoin should be protected. An effective sunscreen should be used any time you are outside (consult your physician for a recommendation of an SPF level which will provide you with the necessary high level of protection).

For extended sun exposure, protective clothing, like a hat, should be worn. Do not use artificial sunlamps while you are using tretinoin. If you do become sunburned, stop your therapy with tretinoin until your skin has recovered.

Avoid excessive exposure to wind or cold. Extremes of climate tend to dry or burn normal skin. Skin treated with tretinoin may be more vulnerable to these extremes.

Your physician can recommend ways to manage your acne treatment under such conditions. Possible problems. The skin of certain sensitive individuals may become excessively red, swollen, blistered or crusted.

If you are experiencing severe or persistent irritation, discontinue the use of tretinoin and consult your physician. There have been reports that, in some patients, areas treated with tretinoin developed a temporary increase or decrease in the amount of skin pigment (color) present. The pigment in these areas returned to normal either when the skin was allowed to adjust to tretinoin or therapy was discontinued.

Use other medications only on your physician’s advice. Only your physician knows which other medications may be helpful during treatment and will recommend them to you if necessary. Follow the physician’s instructions carefully.

In addition, you should avoid preparations that may dry or irritate your skin. These preparations may include certain astringents, toiletries containing alcohol, spices or lime, or certain medicated soaps, shampoos and hair permanent solutions. Do not allow anyone else to use this medication.

Do not use other medications with tretinoin which are not recommended by your doctor. The medications you have used in the past might cause unnecessary redness or peeling. If you are pregnant, think you are pregnant or are nursing an infant: No studies have bee… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 148 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton Label - 20 g NDC 21922- 079 -25 Tretinoin Cream USP, 0.025% For Topical Use Only Net Wt. 20 g Rx only Carton Label - 45 g NDC 21922- 079 -06 Tretinoin Cream USP, 0.025% For Topical Use Only Net Wt. 45 g Rx only Carton Label - 20 g NDC 21922- 078 -25 Tretinoin Cream USP, 0.05% For Topical Use Only Net Wt.

20 g Rx only Carton Label - 45 g NDC 21922- 078 -06 Tretinoin Cream USP, 0.05% For Topical Use Only Net Wt. 45 g Rx only Carton Label - 20 g NDC 21922- 077 -25 Tretinoin Cream USP, 0.1% For Topical Use Only Net Wt. 20 g Rx only Carton Label - 45 g NDC 21922- 077 -06 Tretinoin Cream USP, 0.1% For Topical Use Only Net Wt.

45 g Rx only tret-0.025%-crt-20gm tret-0.025%-crt-45gm cart-20gm-05 cart-45gm-05 cart-20gm-01 cart-45gm-01

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Tretinoin — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tretinoin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$5.59M
Claims incl. refills
77.6K
Beneficiaries
59.9K
Spend / beneficiary
$93.38
Spend / claim
$72.01
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 21922-0076-05 · Encube 21922-0078-06 · Encube →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.