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Tretinoin 1 mg/g Cream — NDC 16714-0250-02 package photo

Tretinoin 1 mg/g Cream

by NORTHSTAR RX LLC · 1 TUBE in 1 CARTON (16714-250-02) / 45 g in 1 TUBE
NDC 16714-0250-02
🏷️ FDA NDC (as labeled) 16714-250-02 billing pads the product segment with a zero
This package
Contains45 g in 1 tube Cost per g$0.7625 NADAC Per package$34.31 / 45 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.47/unit · Part D plans $1.79/unit — full pricing hub ↓
Also comes in: 20 g 16714-0250-01
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 16714-250-02
Product NDC 16714-250
11-digit billing NDC 16714025002
NCPDP billing unit GM — per gram (weight)
RxCUI 198300
UNII 5688UTC01R
Application # ANDA211645
SPL Set ID de3e7308-1212-4727-b541-568a84dac48a
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 2019-01-22
Route TOPICAL
Dosage form CREAM
Substance TRETINOIN
GPI-14 90050030003710
GPI class Tretinoin
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 16714-250-02 — 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 → 16714-0250-02. 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.

🏭 Manufacturer & labeler

LabelerNORTHSTAR RX LLC
Application holderSUN PHARMA CANADA INC
FDA applicationANDA211645 (ANDA)
Labeler code16714
First marketedJan 2019
Product typeHuman Prescription Drug
Portfolio414 products on file
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.

🩺 Clinical

Label name TRETINOIN 0.1% CREAM Ingredient Tretinoin
📗 Our plain-language guide HelloPharmacist
  • Honestly, it won't erase wrinkles — and the label is pretty direct about that. What it's approved to do is help reduce the appearance of fine wrinkles as part of a full routine tha...
  • Will tretinoin actually get rid of my wrinkles?
  • Redness, peeling, and irritation in the first couple of weeks are very common and usually mean your skin is adjusting — not that something is wrong. If it's tolerable, try hanging...
  • My skin is really red and peeling after the first week — should I stop?
📖 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.

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.

💊 What it looks like

Color yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 $0.763 $34.31 / 45 g
Medicaid paysCMS SDUD · 12 mo $1.47 $66.22 / 45 g
Medicare drug plans payPart D · Q2 2026 $1.79 $80.58 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Sep 2022 Jan 2024 Mar 2026 Aug 2026 $2.614 $0.763
▼ Down 67% over the last 15 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tretinoin 1 mg/gthis 16714-0250-02 NORTHSTAR 1 tube $0.763 AB Availability likely
Tretinoin 1 mg/g 21922-0077-06 Encube 1 tube $0.763 AB Availability likely
Tretinoin 1 mg/g 72578-0153-08 Viona 1 tube $0.763 AB Availability likely
Tretinoin 1 mg/g 00378-8084-20 Mylan 1 tube $0.957 AB Availability likely +26%
Tretinoin 1 mg/g 00574-2201-20 Padagis 1 tube $0.957 AB Availability likely +26%
Tretinoin 1 mg/g 51672-1395-00 Sun 1 tube $0.957 AB Availability likely +26%
Tretinoin 1 mg/g 62332-0807-20 Alembic 1 tube $0.957 AB Availability likely +26%
Retin-A 1 mg/g 00187-5164-20 Bausch 1 tube $0.960 AB FDA listed +26%
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

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 16714-0250-02, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
8.1K
Units reimbursed last 4 qtrs
370K
Gross reimbursed last 4 qtrs
$544.4K
Avg / prescription
$66.83
Avg / unit
$1.4715
Latest quarter Q4 2025
2.3KRx
Medicaid pays / g
$1.4715
gross reimbursed
vs
NADAC / g
$0.7625
acquisition cost
=
Spread
+$0.7090
+93% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
77% FFS 23% MCO
Fee-for-service · 6,233 Rx Managed care · 1,914 Rx
State Medicaid map
Alaska: 495 units · 67.5 per 100k residents AK Maine: no data reported ME Washington: 26,635 units · 341 per 100k residents WA Idaho: 4,545 units · 231 per 100k residents ID Montana: 945 units · 83.5 per 100k residents MT North Dakota: 1,125 units · 144 per 100k residents ND Minnesota: no data reported MN Wisconsin: 2,250 units · 38.1 per 100k residents WI Michigan: 465 units · 4.6 per 100k residents MI New York: 62,190 units · 318 per 100k residents NY Vermont: 855 units · 132 per 100k residents VT New Hampshire: no data reported NH Oregon: 540 units · 12.8 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 14,670 units · 117 per 100k residents IL Indiana: no data reported IN Ohio: 2,250 units · 19.1 per 100k residents OH Pennsylvania: 1,530 units · 11.8 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 207,420 units · 532 per 100k residents CA Utah: 4,950 units · 145 per 100k residents UT Colorado: 1,395 units · 23.7 per 100k residents CO Nebraska: no data reported NE Missouri: 1,755 units · 28.3 per 100k residents MO Kentucky: 900 units · 19.9 per 100k residents KY West Virginia: no data reported WV Virginia: 2,385 units · 27.4 per 100k residents VA Maryland: 8,255 units · 134 per 100k residents MD Connecticut: 495 units · 13.7 per 100k residents CT Rhode Island: no data reported RI Arizona: 855 units · 11.5 per 100k residents AZ New Mexico: 3,780 units · 179 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 495 units · 34.5 per 100k residents HI Texas: 18,810 units · 61.7 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.6532
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 532 /100k
2 Washington 341 /100k
3 New York 318 /100k
4 Idaho 231 /100k
5 New Mexico 179 /100k
6 Utah 145 /100k
7 North Dakota 144 /100k
8 Maryland 134 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube this page16714-0250-02 8,147 Rx · $544,435
1 tube16714-0250-01 2,690 Rx · $104,610
Drug total (last 4 qtrs): 10,837 Rx · 429,355 units · $649,045 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Tretinoin — the ingredient across all brands.

Top reported reactions

Pain598
Vomiting498
Rash477
Nausea453
Headache434
Diarrhoea414
Erythema412

Age at onset

Neonate9
Infant3
Child36
Adolescent111
Adult997
Elderly212

Reporter sex

0 reports

Serious outcomes

Hospitalization1,706
Life-threatening498
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 926 433
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
16714-0250-01 1 TUBE in 1 CARTON (16714-250-01) / 20 g in 1 TUBE $0.9575 / g $19.15 2022-02-25 Active
16714-0250-02 You're viewing this 1 TUBE in 1 CARTON (16714-250-02) / 45 g in 1 TUBE $0.7625 / g $34.31 2022-02-25 Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.7625 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 75% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 16714-0250-02?
NDC 16714-0250-02 is listed by the FDA — 1 tube in 1 carton / 45 g in 1 tube.
What NDC number is used to bill for this package of Tretinoin 1 mg/g Cream?
Bill NDC 16714-0250-02 — the 11-digit billing format is 16714025002. 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 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 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.

Alteration 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 32 words

Warnings Keep out of reach of children. Keep tube tightly closed. Do not expose to heat. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

🤒 Adverse Reactions 103 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. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin. To date, all adverse effects of tretinoin have been reversible upon discontinuance of therapy (see Dosage and Administration Section).

🔄 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 parietal 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 has 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 31 words

How Supplied Tretinoin Cream USP, 0.1% is supplied as: 20g 45g 16714-250-01 16714-250-02 Storage Conditions Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

📦 Storage and Handling 18 words

Storage Conditions Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

📋 Description 60 words

Description Tretinoin Cream USP, 0.1% is used for the topical treatment of acne vulgaris. Tretinoin Cream contains tretinoin in 0.1% by weight, in a hydrophilic cream vehicle of butylated hydroxytoluene, isopropyl myristate, polyoxyl stearate type II, purified water, sorbic acid, stearic acid, stearyl alcohol and xanthan gum. Chemically, tretinoin is all-trans -retinoic acid and has the following structure: Chemical Structure

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