adapalene

adapalene
SPL v4
SPL
SPL Set ID 0c96c096-73f8-5bc2-e063-6294a90a235f
Route
topical
Published
Effective Date 2024-04-17
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 2024-04-15

Purpose

Acne treatment

Description

Drug Facts


Medication Information

Warnings

For external use only

Purpose

Acne treatment

Directions

Adults and children 12 years of age and older:

  • use oncedaily
  • 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
  • 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.

Description

Drug Facts

Questions?

1-866-923-4914

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.

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

Adapalene USP, 0.1% (retinoid)

read consumer information leaflet

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

NDC 11822-0062-1

ADAPALENE

GEL USP, 0.1%

ACNE TREATMENT

PREVIOUSLY AVAILABLE

ONLY BY PRESCRIPTION

DERMATOLOGIST DEVELOPED

FDA APPROVED

ONCE DAILY TOPICAL RETINOID*

RYSHI

COMPARE TO THE ACTIVE

INGREDIENT IN DIFFERIN ®GEL

* Read consumer information leaflet before use

NET WT 0.5 OZ (15 g)


Structured Label Content

Warnings (WARNINGS)

For external use only

Purpose (PURPOSE)

Acne treatment

Directions (DIRECTIONS)

Adults and children 12 years of age and older:

  • use oncedaily
  • 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 (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.

Questions? (QUESTIONS?)

1-866-923-4914

Use (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.

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.
Active Ingredient (ACTIVE INGREDIENT)

Adapalene USP, 0.1% (retinoid)

read consumer information leaflet

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)

NDC 11822-0062-1

ADAPALENE

GEL USP, 0.1%

ACNE TREATMENT

PREVIOUSLY AVAILABLE

ONLY BY PRESCRIPTION

DERMATOLOGIST DEVELOPED

FDA APPROVED

ONCE DAILY TOPICAL RETINOID*

RYSHI

COMPARE TO THE ACTIVE

INGREDIENT IN DIFFERIN ®GEL

* Read consumer information leaflet before use

NET WT 0.5 OZ (15 g)


Advanced Ingredient Data


Raw Label Data

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