Humane Acne Wash

Humane Acne Wash
SPL v3
SPL
SPL Set ID 1d25fb25-a3d2-4c6b-a975-be7b90b70265
Route
TOPICAL
Published
Effective Date 2019-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Water Carboxypolymethylene Cocamidopropyl Betaine Gluconolactone Sodium Benzoate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-01

Description

Benzoyl Peroxide 10%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 10%

Use

for the treatment of acne.

Warnings

For external use only.

Directions

New User: Test 1-2 small affected areas for sensitivity for 3 days. If no discomfort occurs, apply acne wash and gently massage into damp skin. Wait 3-5 minutes for wash to absorb. Rinse thoroughly.

Do Not Use
  • If you are sensitive to Benzoyl Peroxide or have very sensitive skin.
  • Using other topical acne drugs at the same time or right after use of this product may increase dryness, redness or irritation of the skin.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Active Ingredient

Benzoyl Peroxide 10%

Package Labeling:

Inactive Ingredients

Aqua (Deionized Water), Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide.

When Using This Product
  • Avoid contact with and near eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.
Stop Use and Ask A Doctor

if excessive irritation occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

for the treatment of acne.

Purpose

Acne Treatment

Warnings

For external use only.

Directions

New User: Test 1-2 small affected areas for sensitivity for 3 days. If no discomfort occurs, apply acne wash and gently massage into damp skin. Wait 3-5 minutes for wash to absorb. Rinse thoroughly.

Do Not Use (Do not use)
  • If you are sensitive to Benzoyl Peroxide or have very sensitive skin.
  • Using other topical acne drugs at the same time or right after use of this product may increase dryness, redness or irritation of the skin.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Active Ingredient (Active ingredient)

Benzoyl Peroxide 10%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide.

When Using This Product (When using this product)
  • Avoid contact with and near eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.
Stop Use and Ask A Doctor (Stop use and ask a doctor)

if excessive irritation occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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