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Retin-A Tretinoin .25 mg/g Cream — NDC 00187-5160-45 package photo

Retin-A Tretinoin .25 mg/g Cream

by Bausch Health US, LLC · 1 TUBE in 1 CARTON (0187-5160-45) / 45 g in 1 TUBE
NDC 00187-5160-45
🏷️ FDA NDC (as labeled) 0187-5160-45 billing pads the labeler segment with a zero
This package
Contains45 g in 1 tube Cost per g$0.7203 NADAC Per package$32.41 / 45 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.8593/unit · Part D plans $0.4978/unit — full pricing hub ↓
Also comes in: 20 g 00187-5160-20
Rx only Brand 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) 0187-5160-45
Product NDC 0187-5160
11-digit billing NDC 00187516045
NCPDP billing unit GM — per gram (weight)
UNII 5688UTC01R
UPC 0301875170455, 0301875172459
Application # NDA019049
SPL Set ID 9556d73d-c573-4e0a-9feb-764ce2d1107b
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1988-10-30
Route TOPICAL
Dosage form CREAM
Substance TRETINOIN
GPI-14 90050030003703
GPI class Retin-A
GCN Seq No 005799
GCN 22882
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 RETIN-A 0.025% CREAM
FDB brand name Retin-A
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 0187-5160-45 — 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 → 00187-5160-45. 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

LabelerBausch Health US, LLC
Application holderBAUSCH HEALTH US LLC
FDA applicationNDA019049 (NDA)
Labeler code00187
First marketedOct 1988
Product typeHuman Prescription Drug
Portfolio51 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 RETIN-A 0.025% CREAM Ingredient Tretinoin
📖 What it is MedlinePlus · NLM

Tretinoin is used to treat acne. Tretinoin is also used to reduce fine wrinkles. Tretinoin is in a class of medications called retinoids. It works by increasing production of new skin cells and unclogging pores.

Read the full MedlinePlus article ↗
📗 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 $0.720 $32.41 / 45 g
Medicaid paysCMS SDUD · 12 mo $0.8593 $38.67 / 45 g
Medicare drug plans payPart D · Q2 2026 $0.4978 $22.40 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Apr 2021 Feb 2022 Nov 2023 $1.690 $0.720
▼ Down 57% over the last 3 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 .25 mg/g 21922-0079-06 Encube 1 tube $0.468 AB Availability likely save 35%
Tretinoin .25 mg/g 00378-8082-20 Mylan 1 tube $0.554 AB Availability likely save 23%
Tretinoin .25 mg/g 00472-0117-20 Actavis 1 tube $0.554 AB Availability likely save 23%
Tretinoin .25 mg/g 00574-2225-20 Padagis 1 tube $0.554 AB Availability likely save 23%
Tretinoin .25 mg/g 16714-0270-01 NORTHSTAR 1 tube $0.554 AB Availability likely save 23%
Tretinoin .25 mg/g 51672-1407-00 Sun 1 tube $0.554 AB Availability likely save 23%
Tretinoin .25 mg/g 62332-0809-20 Alembic 1 tube $0.554 AB Availability likely save 23%
Retin-A .25 mg/gthis 00187-5160-45 Bausch 1 tube $0.720 AB FDA listed
Retin-A .25 mg/g 00187-5170-15 Bausch 1 tube $0.960 AB FDA listed +33%
Tretinoin .25 mg/g 00378-8086-15 Mylan 1 tube $3.779 AB Availability likely +425%
Tretinoin .25 mg/g 59651-0713-14 Aurobindo 1 tube $3.779 AB Availability likely +425%
Tretinoin .25 mg/g 00574-2325-15 Padagis 1 tube $3.779 AB Availability likely +425%
Tretinoin .25 mg/g 21922-0057-04 Encube 1 tube $3.779 AB Availability likely +425%
Tretinoin .25 mg/g 46708-0809-20 Alembic 1 tube AB FDA listed
Tretinoin .25 mg/g 50090-0651-00 A-S 1 tube AB FDA listed
Tretinoin .25 mg/g 50090-3128-00 A-S 1 tube AB FDA listed
Tretinoin .25 mg/g 50090-7171-00 A-S 1 tube AB FDA listed
Tretinoin Cream .25 mg/g 62032-0414-20 Obagi 1 tube AB FDA listed
Tretinoin .25 mg/g 68071-3825-02 NuCare 1 tube AB FDA listed
Tretinoin .25 mg/g 68071-3888-02 NuCare 1 tube AB FDA listed
Tretinoin .25 mg/g 68071-3945-02 NuCare 1 tube AB FDA listed
Tretinoin .25 mg/g 68788-4069-02 Preferred 1 tube AB FDA listed
Tretinoin .25 mg/g 68788-8857-02 Preferred 1 tube AB FDA listed
Tretinoin .25 mg/g 72162-2135-02 Bryant 1 tube AB FDA listed
Tretinoin .25 mg/g 71335-2898-01 Bryant 1 tube AB FDA listed
Tretinoin .25 mg/g 67296-2287-04 Redpharm 1 tube AB FDA listed
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
1988
On the market since
Oct 1988
📍
2026
Currently FDA-listed
38 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 00187-5160-45, 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
140.2K
Units reimbursed last 4 qtrs
6.2M
Gross reimbursed last 4 qtrs
$5.34M
Avg / prescription
$38.12
Avg / unit
$0.8593
Latest quarter Q4 2025
601Rx
Medicaid pays / g
$0.8593
gross reimbursed
vs
NADAC / g
$0.7203
acquisition cost
=
Spread
+$0.1390
+19% 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
51% FFS 49% MCO
Fee-for-service · 70,802 Rx Managed care · 69,388 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 30,260 units · 2,673 per 100k residents MT North Dakota: no data reported ND Minnesota: 243,835 units · 4,250 per 100k residents MN Wisconsin: 229,885 units · 3,890 per 100k residents WI Michigan: no data reported MI New York: 1,834,280 units · 9,372 per 100k residents NY Vermont: 22,945 units · 3,546 per 100k residents VT New Hampshire: no data reported NH Oregon: 24,840 units · 587 per 100k residents OR Nevada: 9,315 units · 292 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 42,450 units · 1,324 per 100k residents IA Illinois: no data reported IL Indiana: 167,965 units · 2,448 per 100k residents IN Ohio: no data reported OH Pennsylvania: 520,675 units · 4,017 per 100k residents PA New Jersey: 630 units · 6.8 per 100k residents NJ Massachusetts: 444,550 units · 6,350 per 100k residents MA California: 273,310 units · 701 per 100k residents CA Utah: 8,655 units · 253 per 100k residents UT Colorado: 196,070 units · 3,336 per 100k residents CO Nebraska: 8,955 units · 453 per 100k residents NE Missouri: 93,570 units · 1,510 per 100k residents MO Kentucky: 184,408 units · 4,074 per 100k residents KY West Virginia: 58,275 units · 3,292 per 100k residents WV Virginia: 90,460 units · 1,038 per 100k residents VA Maryland: 64,415 units · 1,042 per 100k residents MD Connecticut: 246,735 units · 6,822 per 100k residents CT Rhode Island: no data reported RI Arizona: 161,780 units · 2,177 per 100k residents AZ New Mexico: 990 units · 46.8 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 421,740 units · 3,892 per 100k residents NC South Carolina: 86,615 units · 1,612 per 100k residents 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: no data reported HI Texas: no data reported TX Florida: 751,825 units · 3,325 per 100k residents FL
Units reimbursed · per 100k residents
6.89,372
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 New York 9,372 /100k
2 Connecticut 6,822 /100k
3 Massachusetts 6,350 /100k
4 Minnesota 4,250 /100k
5 Kentucky 4,074 /100k
6 Pennsylvania 4,017 /100k
7 North Carolina 3,892 /100k
8 Wisconsin 3,890 /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 page00187-5160-45 140,190 Rx · $5,344,278
1 tube00187-5160-20 76,503 Rx · $1,604,514
Drug total (last 4 qtrs): 216,693 Rx · 7,842,204 units · $6,948,792 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 Retin-A — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Retin-A. 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
$201K
Claims incl. refills
8K
Beneficiaries
6.3K
Spend / beneficiary
$31.82
Spend / claim
$25.25
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 Retin-A (this brand).

Top reported reactions

Pain564
Vomiting489
Nausea427
Rash417
Headache410
Diarrhoea401
Paraesthesia385

Age at onset

Neonate8
Infant3
Child36
Adolescent106
Adult960
Elderly201

Reporter sex

7,639 reports
Male · 24%
Female · 75%
Unknown · 1%

Serious outcomes

Hospitalization1,610
Death855
Life-threatening493
Disabling343
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 644 0
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
00187-5160-20 1 TUBE in 1 CARTON (0187-5160-20) / 20 g in 1 TUBE $0.7209 / g $14.42 1988-10-30 Active
00187-5160-45 You're viewing this 1 TUBE in 1 CARTON (0187-5160-45) / 45 g in 1 TUBE $0.7203 / g $32.41 1988-10-30 Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.7203 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 65% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00187-5160-45?
NDC 00187-5160-45 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 Retin-A Tretinoin .25 mg/g Cream?
Bill NDC 00187-5160-45 — the 11-digit billing format is 00187516045. 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 36 words

INDICATIONS AND USAGE RETIN-A 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 ~1 min read

DOSAGE AND ADMINISTRATION RETIN-A 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 overapplication 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 2 to 3 weeks but more than 6 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 RETIN-A (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.

🤒 Adverse Reactions 121 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 RETIN-A. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with RETIN-A. To date, all adverse effects of RETIN-A have been reversible upon discontinuance of therapy (see DOSAGE AND ADMINISTRATION ).

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 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 RETIN-A. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of RETIN-A 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 RETIN-A. 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 51 words

Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of RETIN-A did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. GELS ARE FLAMMABLE. Note: Keep away from heat and flame. Keep tube tightly closed.

🆘 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 94 words

HOW SUPPLIED RETIN-A (tretinoin) is supplied as: RETIN-A Cream RETIN-A Gel NDC Code RETIN-A Strength/ Form RETIN-A Qty. NDC Code RETIN-A Strength/ Form RETIN-A Qty. 0187-5160-20 0.025% Cream 20 g 0187-5172-15 0.01% Gel 15 g 0187-5160-45 0.025% Cream 45 g 0187-5172-45 0.01% Gel 45 g 0187-5162-20 0.05% Cream 20 g 0187-5170-15 0.025% Gel 15 g 0187-5162-45 0.05% Cream 45 g 0187-5170-45 0.025% Gel 45 g 0187-5164-20 0.1% Cream 20 g 0187-5164-45 0.1% Cream 45 g Storage Conditions: RETIN-A Gel, 0.025% and 0.01%: store below 86°F.

RETIN-A Cream, 0.1%, 0.05%, and 0.025%: store below 80°F.

📦 Storage and Handling 19 words

Storage Conditions: RETIN-A Gel, 0.025% and 0.01%: store below 86°F. RETIN-A Cream, 0.1%, 0.05%, and 0.025%: store below 80°F.

📋 Description 111 words

DESCRIPTION RETIN-A Gel and Cream, containing tretinoin, are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert -butyl alcohol and brucine sulfate) 90% w/w. RETIN-A (tretinoin) Cream contains tretinoin in one 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: 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.