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NDC 51672-2143-01 Adapalene 1 mg/g Details
Adapalene 1 mg/g
Adapalene is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. The primary component is ADAPALENE.
MedlinePlus Drug Summary
Adapalene is used to treat acne in adults and children 12 years of and older. Adapalene is in a class of medications called retinoid-like compounds. It works by stopping pimples from forming under the surface of the skin.
Related Packages: 51672-2143-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Adapalene
Product Information
| NDC | 51672-2143 |
|---|---|
| Product ID | 51672-2143_740cf78a-9728-4245-9ca2-448d2c9a997d |
| Associated GPIs | |
| GCN Sequence Number | 026436 |
| GCN Sequence Number Description | adapalene GEL (GRAM) 0.1 % TOPICAL |
| HIC3 | L9B |
| HIC3 Description | VITAMIN A DERIVATIVES |
| GCN | 29300 |
| HICL Sequence Number | 011233 |
| HICL Sequence Number Description | ADAPALENE |
| Brand/Generic | Generic |
| Proprietary Name | Adapalene |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Adapalene |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/g |
| Substance Name | ADAPALENE |
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215940 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 51672-2143-01 (51672214301)
| NDC Package Code | 51672-2143-1 |
|---|---|
| Billing NDC | 51672214301 |
| Package | 1 TUBE in 1 CARTON (51672-2143-1) / 15 g in 1 TUBE |
| Marketing Start Date | 2022-01-14 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.50267 |
| Pricing Unit | GM |
| Effective Date | 2023-12-20 |
| NDC Description | ADAPALENE 0.1% GEL |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL a9ca1f7a-71c3-4814-9366-e7e5760bf32c Details
Warnings
For external use only
Do not use
- on damaged skin (cuts, abrasions, eczema, sunburn)
- if you are allergic to adapalene or any of the ingredients in this product.
When using this product
- limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors
- do not wax to remove hair in areas where the product has been applied
- during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe
- irritation (redness, itching, dryness, burning) is more likely to occur:
- in the first few weeks of use
- if using more than one topical acne medication at a time
- but irritation usually lessens with continued use of this product
- it may take up to 3 months of once daily use to see results
- avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.
- wash hands after use
Stop use and ask doctor if
- you become pregnant, or are planning to become pregnant, while using the product
- you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
- irritation becomes severe
- you see no improvement after 3 months of once daily use
Directions
Adults and children 12 years of age and older:
- use once daily
- clean the skin gently and pat dry before applying the product
- cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face.
- do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.
Children under 12 years of age: ask a doctor
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
Adapalene Gel USP, 0.1%
Acne Treatment
Frequently Asked Questions
What is adapalene gel and what is it used for?
- Adapalene gel is a topical retinoid medication used for the treatment of acne in people age 12 years and older.
- Use only one time a day.
What should I know before using the product?
- If pregnant or breast-feeding, ask a doctor before use.
- Some other retinoid drugs have been shown to cause birth defects. There is no specific evidence that adapalene gel 0.1% causes birth defects in humans when used topically as directed.
- Do not use adapalene gel if you are allergic to adapalene or any of the ingredients in this product.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
How often do I apply the product?
- Apply this product only one time a day and try to apply the product at the same time each day.
How do I apply the product?
- Gently clean the affected areas using a mild (non-irritating) cleanser and pat dry.
- Apply adapalene gel as a thin layer to the affected areas of the skin only one time a day. For example, if you get acne on the face, clean, dry and apply the product to the entire face. Adapalene gel is not a spot treatment and should not be used to treat a single pimple.
- Avoid product contact with eyes, lips and mouth. If contact occurs, immediately flush the area with water.
- Do not apply product to damaged skin (cuts, abrasions, eczema, or sunburn).
- Wash hands after use.
How long will it take for adapalene gel to work?
- It may take up to 3 months of daily use for results to appear.
- Do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.
What do I do if I need to be in the sun?
- When possible, limit sun exposure, including light from tanning beds.
- When going outdoors, use sunscreen as labeled. Your skin may be more sensitive while using adapalene gel. If you use this product during the day, allow it to dry before applying sunscreen.
Can I use a moisturizer if my skin is dry?
- Yes, use of a moisturizer may help decrease dryness and other signs of irritation. Avoid products containing alpha hydroxy or glycolic acids which may worsen irritation.
When is my skin most likely to become irritated? And what do I do?
- Irritation (redness, itching, dryness, burning) is more likely to occur:
- In the first few weeks of use.
- If using abrasive skin cleansers, products with drying effects or more than one topical acne medication at a time. You may want to delay starting adapalene gel until any irritation from using the other product(s) has gone away.
- Moisturizers may be used.
- Irritation usually lessens after 4 weeks of continued use.
What do I do if my skin becomes severely irritated?
- If irritation becomes severe (overly bothersome), stop use and ask a doctor before using the product again.
Can I remove unwanted facial hair by waxing while using this product?
- Do not use wax to remove hair in areas where the product has been applied because it may worsen skin irritation.
What ingredients are used in adapalene gel?
- Adapalene gel contains:
The active ingredient is adapalene USP, 0.1%. The other ingredients are: carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, sodium hydroxide.
How should I store this product?
- Adapalene gel should be stored at room temperature [68° to 77°F]. Protect from freezing.
- Do not use the product after the expiry date marked on the packaging.
Other Questions? Where can I get more information?
Phone: 1-866-923-4914
Mfd. by: Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1
Made in Canada
Issued: November 2021
5225941 47
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
INGREDIENTS AND APPEARANCE
| ADAPALENE
adapalene gel |
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| Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(51672-2143) | |
Revised: 1/2022
Document Id: 740cf78a-9728-4245-9ca2-448d2c9a997d
Set id: a9ca1f7a-71c3-4814-9366-e7e5760bf32c
Version: 3
Effective Time: 20220113