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NDC 70000-0043-01 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 Cardinal Health (Leader) 70000. 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: 70000-0043-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Adapalene
Product Information
| NDC | 70000-0043 |
|---|---|
| Product ID | 70000-0043_99da7230-9480-4b05-91c7-f8609f34ab01 |
| Associated GPIs | 90050003004010 |
| 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 | Cardinal Health (Leader) 70000 |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091314 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0043-01 (70000004301)
| NDC Package Code | 70000-0043-1 |
|---|---|
| Billing NDC | 70000004301 |
| Package | 1 TUBE in 1 CARTON (70000-0043-1) / 15 g in 1 TUBE |
| Marketing Start Date | 2019-02-19 |
| 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 9e9c882c-4c57-4bb1-b1eb-66cf52ebc848 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 become 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 result
- avoid product contact eyes, lips, and month. If contact occurs immediately flush the area with water.
- wash hands after use
Stop use and ask a doctor if
- you become pregnant, or planning to become pregnant while using this product
- you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
- irritation become 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 in 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
Inactive ingredients
Principal Display Panel
COMPARE TO DIFFERIN® GEL active ingredient†
Adapalene Gel
USP, 0.1% | Acne Treatment
Previously available only by prescription
FDA-approved
Dermatologist Developed
Once Daily Topical Retinoid*
Oil-Free
Fragrance free
Dermatologist developed and tested
*Read consumer information leaflet before use
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON AND ENCLOSED CONSUMER INFORMATION LEAFLET FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
†This product is not manufactured or distributed by Galderma Laboratories, L.P. distributor of Differin® Gel.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
INGREDIENTS AND APPEARANCE
| ADAPALENE
adapalene gel |
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| Labeler - Cardinal Health (Leader) 70000 (063997360) |
Revised: 11/2022
Document Id: 99da7230-9480-4b05-91c7-f8609f34ab01
Set id: 9e9c882c-4c57-4bb1-b1eb-66cf52ebc848
Version: 3
Effective Time: 20221107