Adapalene

Adapalene
SPL v4
SPL
SPL Set ID 164f52fa-3050-3eea-e063-6394a90a6f70
Route
TOPICAL
Published
Effective Date 2025-09-08
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 Phenoxyethanol Poloxamer 182 Propylene Glycol Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-07-19

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Drug Facts

Use
  • For the treatment of acne
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9

If pregnant or breast-feeding, ask a doctor before use.

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 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

Do Not Use
  • on damaged skin (cuts, abrasions, eczema, sunburn)
  • if you are allergic to adapalene or any of the ingredients in this product.
Questions?

1-800-910-6874

Active Ingredient

Adapalene USP, 0.1% (retinoid)

read consumer information leaflet

Other Information
  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • protect from freezing
Inactive Ingredients

carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

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
Principal Display Panel 15 G Tube Carton

Adapalene

Gel USP,

0.1%

Acne Treatment

  • Previously available by

    prescription only
  • Once daily topical retinoid*
  • FDA approved

Dermatologist

Tested

up&up

*Read consumer information

leaflet before use

NET WT 0.5 OZ (15 g)


Structured Label Content

Use
  • For the treatment of acne
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a doctor before use.

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 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

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.
Questions?

1-800-910-6874

Active Ingredient (Active ingredient)

Adapalene USP, 0.1% (retinoid)

read consumer information leaflet

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • protect from freezing
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

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 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 (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
Principal Display Panel 15 G Tube Carton (PRINCIPAL DISPLAY PANEL - 15 g Tube Carton)

Adapalene

Gel USP,

0.1%

Acne Treatment

  • Previously available by

    prescription only
  • Once daily topical retinoid*
  • FDA approved

Dermatologist

Tested

up&up

*Read consumer information

leaflet before use

NET WT 0.5 OZ (15 g)


Advanced Ingredient Data


Raw Label Data

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