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TRETINOIN 1 mg/g Cream — NDC 00574-2201-45 package photo

TRETINOIN 1 mg/g Cream

by Padagis US LLC · 1 TUBE in 1 CARTON (0574-2201-45) / 45 g in 1 TUBE
NDC 00574-2201-45
🏷️ FDA NDC (as labeled) 0574-2201-45 billing pads the labeler 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 $1.41/unit · Part D plans $2.06/unit — full pricing hub ↓
Also comes in: 20 g 00574-2201-20
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 13, 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) 0574-2201-45
Product NDC 0574-2201
11-digit billing NDC 00574220145
NCPDP billing unit GM — per gram (weight)
UNII 5688UTC01R
Application # ANDA075213
SPL Set ID 4889c7f8-37d0-4f1a-9829-bca107806586
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 2017-03-30
Route TOPICAL
Dosage form CREAM
Substance 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 0574-2201-45 — a 4-4-2 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 labeler segment → 00574-2201-45. 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

LabelerPadagis US LLC
Application holderPADAGIS US LLC
FDA applicationANDA075213 (ANDA)
Labeler code00574
First marketedMar 2017
Product typeHuman Prescription Drug
Portfolio63 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.

🧪 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 13A4J4NH9I
    A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
  • 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.

8 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 $1.41 $63.56 / 45 g
Medicare drug plans payPart D · Q2 2026 $2.06 $92.61 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $2.614 $0.763
▼ Down 66% over the last 24 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 00574-2201-45 Padagis 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 16714-0250-01 NORTHSTAR 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

🏛️
2017
On the market since
Mar 2017
📍
2026
Currently FDA-listed
9 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 00574-2201-45, 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
22K
Units reimbursed last 4 qtrs
1M
Gross reimbursed last 4 qtrs
$1.42M
Avg / prescription
$64.52
Avg / unit
$1.4125
Latest quarter Q4 2025
5.1KRx
Medicaid pays / g
$1.4125
gross reimbursed
vs
NADAC / g
$0.7625
acquisition cost
=
Spread
+$0.6500
+85% 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
81% FFS 19% MCO
Fee-for-service · 17,889 Rx Managed care · 4,094 Rx
State Medicaid map
Alaska: 540 units · 73.7 per 100k residents AK Maine: no data reported ME Washington: 12,185 units · 156 per 100k residents WA Idaho: 2,160 units · 110 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 675 units · 11.8 per 100k residents MN Wisconsin: 5,130 units · 86.8 per 100k residents WI Michigan: 1,170 units · 11.7 per 100k residents MI New York: 128,590 units · 657 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 585 units · 13.8 per 100k residents OR Nevada: 4,500 units · 141 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,530 units · 166 per 100k residents SD Iowa: no data reported IA Illinois: 7,785 units · 62.0 per 100k residents IL Indiana: 1,170 units · 17.1 per 100k residents IN Ohio: 16,355 units · 139 per 100k residents OH Pennsylvania: 6,075 units · 46.9 per 100k residents PA New Jersey: 2,295 units · 24.7 per 100k residents NJ Massachusetts: 1,710 units · 24.4 per 100k residents MA California: 669,215 units · 1,717 per 100k residents CA Utah: 1,350 units · 39.5 per 100k residents UT Colorado: 2,475 units · 42.1 per 100k residents CO Nebraska: no data reported NE Missouri: 1,935 units · 31.2 per 100k residents MO Kentucky: 3,395 units · 75.0 per 100k residents KY West Virginia: no data reported WV Virginia: 9,580 units · 110 per 100k residents VA Maryland: 14,030 units · 227 per 100k residents MD Connecticut: 1,935 units · 53.5 per 100k residents CT Rhode Island: no data reported RI Arizona: 3,870 units · 52.1 per 100k residents AZ New Mexico: 2,295 units · 109 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 5,265 units · 73.9 per 100k residents TN North Carolina: 4,050 units · 37.4 per 100k residents NC South Carolina: 1,260 units · 23.5 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 5,490 units · 120 per 100k residents LA Mississippi: 2,565 units · 87.2 per 100k residents MS Alabama: no data reported AL Georgia: 6,075 units · 55.1 per 100k residents GA D.C.: 855 units · 126 per 100k residents DC Hawaii: 14,400 units · 1,003 per 100k residents HI Texas: 59,960 units · 197 per 100k residents TX Florida: 1,665 units · 7.4 per 100k residents FL
Units reimbursed · per 100k residents
7.41,717
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 1,717 /100k
2 Hawaii 1,003 /100k
3 New York 657 /100k
4 Maryland 227 /100k
5 Texas 197 /100k
6 South Dakota 166 /100k
7 Washington 156 /100k
8 Nevada 141 /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 page00574-2201-45 21,983 Rx · $1,418,300
1 tube00574-2201-20 13,224 Rx · $517,659
Drug total (last 4 qtrs): 35,207 Rx · 1,304,051 units · $1,935,959 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
00574-2201-20 1 TUBE in 1 CARTON (0574-2201-20) / 20 g in 1 TUBE $0.9575 / g $19.15 2017-03-30 Active
00574-2201-45 You're viewing this 1 TUBE in 1 CARTON (0574-2201-45) / 45 g in 1 TUBE $0.7625 / g $34.31 2017-04-17 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 62% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00574-2201-45?
NDC 00574-2201-45 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 00574-2201-45 — the 11-digit billing format is 00574220145. 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 39 words

Indications and Usage: Tretinoin gel and cream are 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 ~1 min read

Dosage and Administration: Tretinoin gel or 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. Gel: Excessive application results in “pilling” of the gel, which minimizes the likelihood of over application by the patient. 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 preparations may use cosmetics, but the areas 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 33 words

Warnings: GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE. 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 107 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 a tretinoin preparation. 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. Pregnancy Category C. 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 animal 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 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 56 words

How Supplied: Tretinoin Gel, USP NDC CODE Strength Qty. 0574-2325-15 0.025% 15 g 0574-2325-45 0.025% 45 g 0574-2301-15 0.01% 15 g 0574-2301-45 0.01% 45 g Tretinoin Cream, USP NDC CODE Strength Qty. 0574-2201-20 0.1% 20 g 0574-2201-45 0.1% 45 g 0574-2205-20 0.05% 20 g 0574-2205-45 0.05% 45 g 0574-2225-20 0.025% 20 g 0574-2225-45 0.025% 45 g

📦 Storage and Handling 16 words

Storage Conditions: Tretinoin Gel, USP: store below 30°C (86°F). Tretinoin Cream, USP: store below 27°C (80°F)

📋 Description 115 words

Description: Tretinoin Gel, USP and Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Each gram of tretinoin gel contains tretinoin in either of two strengths, 0.025% (0.25 mg) or 0.01% (0.1 mg) in a gel vehicle of hydroxypropyl cellulose, butylated hydroxytoluene, and alcohol 90% w/w. Each gram of tretinoin cream contains tretinoin in either of three strengths, 0.1% (1 mg), 0.05% (0.5 mg), or 0.025% (0.25 mg) 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. It has a molecular weight of 300.44 and has the following structural formula: chemical-structure-tretinoin.jpg

💬 Information for Patients ~3 min read

PATIENT INSTRUCTIONS 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 TRETINOIN GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE.

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 chances 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 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 medication only on your doctor’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 ha…

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.