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

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

Section 55106-9

Active ingredient

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet


Structured Label Content

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
Warnings and Precautions (34071-1)

Warnings

For external use only

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

Section 55106-9 (55106-9)

Active ingredient

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet


Advanced Ingredient Data


Raw Label Data

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