acne relief (adapalene gel 0.1%)

acne relief (adapalene gel 0.1%)
SPL v2
SPL
SPL Set ID e6380880-5299-0826-e053-2a95a90a1942
Route
topical
Published
Effective Date 2022-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
adapalene (0.1 g)
Inactive Ingredients
carbomer homopolymer type c (allyl pentaerythritol crosslinked) edetate disodium methylparaben poloxamer 182 propylene glycol water sodium hydroxide

Identifiers & Packaging

Marketing Status
anda active Since 2022-08-15

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredient

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet

Indications and Usage

Use

for the treatment of acne

Dosage and Administration

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
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store at room temperature 68º to 77ºF
  • protect from freezing
Section 50565-1

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

Section 50566-9

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
Section 50567-7

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
Section 50570-1

Do not use

  • on damaged skin (cuts, abrasions eczema, sunburn)
  • if you are allergic to adapalene or any of the ingredients in this product
Section 51727-6

Inactive ingredients carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide

Section 51945-4

curist

Acne Relief

Adapalene Gel, 0.1%

Acne Teatment

Once Daily Topical Retinoid*

Fragrance Free

Oil Free

NET WT 1.6 oz (45 g)

Section 53413-1

Questions? Call 1 (888) 721-7115

Section 53414-9

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

Section 55105-1

Purpose

Acne treatment


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet

Indications and Usage (34067-9)

Use

for the treatment of acne

Dosage and Administration (34068-7)

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
Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store at room temperature 68º to 77ºF
  • protect from freezing
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 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50570-1 (50570-1)

Do not use

  • on damaged skin (cuts, abrasions eczema, sunburn)
  • if you are allergic to adapalene or any of the ingredients in this product
Section 51727-6 (51727-6)

Inactive ingredients carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide

Section 51945-4 (51945-4)

curist

Acne Relief

Adapalene Gel, 0.1%

Acne Teatment

Once Daily Topical Retinoid*

Fragrance Free

Oil Free

NET WT 1.6 oz (45 g)

Section 53413-1 (53413-1)

Questions? Call 1 (888) 721-7115

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Acne treatment


Advanced Ingredient Data


Raw Label Data

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