Adapalene Gel Usp 0 1 Percent Delisted

Adapalene Gel Usp 0 1 Percent Delisted
SPL v4
SPL
SPL Set ID e41523dc-61e2-45b5-b2c5-4e87931fd5fc
Route
TOPICAL
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Adapalene (1 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetate Disodium Methylparaben Poloxamer 182 Propylene Glycol Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
ANDA Completed Since 2019-08-30 Until 2027-03-30

Description

Agapalene USP 0.1% (retinoid)* *read consumer information leaflet

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Agapalene USP 0.1% (retinoid)* *read consumer information leaflet

Use
  • For the treatment of acne
Warnings

For external use only

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
Do Not Use
  • on damaged skin (cuts, abrasions eczema, sunburn)
  • if you are allergic to adapalene or any of the ingredients in this product
Product Label
SIGNATURE CARE Acne Treatment
Active Ingredient

Agapalene USP 0.1% (retinoid)*

*read consumer information leaflet

Other Information
  • store at rooms temperature 68º to 77ºF
  • protect from freezing
Inactive Ingredients

carbomer homopolymer, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water, sodium hydroxide

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Differin® Gel active ingredient

ACNE TREATMENT

ADAPALENE GEL USP, 0.1%

  • 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 FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Galderma Laboratories, L.P. distributor of Differin® Gel.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

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
Pregnancy/breastfeeding,

ask a doctor before 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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Use
  • For the treatment of acne
Purpose

Acne treatment

Warnings

For external use only

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
Do Not Use (Do not use)
  • on damaged skin (cuts, abrasions eczema, sunburn)
  • if you are allergic to adapalene or any of the ingredients in this product
Product Label
SIGNATURE CARE Acne Treatment
Active Ingredient (Active ingredient)

Agapalene USP 0.1% (retinoid)*

*read consumer information leaflet

Other Information (Other information)
  • store at rooms temperature 68º to 77ºF
  • protect from freezing
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water, sodium hydroxide

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Differin® Gel active ingredient

ACNE TREATMENT

ADAPALENE GEL USP, 0.1%

  • 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 FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Galderma Laboratories, L.P. distributor of Differin® Gel.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

When Using 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
Pregnancy/breastfeeding, (Pregnancy/Breastfeeding,)

ask a doctor before use.

Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


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