basics 264.005/264ai rev 1 - 264aj

basics 264.005/264ai rev 1 - 264aj
SPL v18
SPL
SPL Set ID 2dddc0ef-352a-4973-8402-15aecddcc43f
Route
topical
Published
Effective Date 2025-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzoyl peroxide (104 mg)
Inactive Ingredients
water cetyl alcohol petrolatum carbomer interpolymer type a (allyl sucrose crosslinked) zinc lactate steareth-2 glycerin potassium cetyl phosphate xanthan gum benzyl alcohol edetate disodium anhydrous laureth-4 butylated hydroxytoluene sodium hydroxide lactic acid menthol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-04-25

Purpose

Acne medication

Description

Benzoyl peroxide 10%


Medication Information

Warnings

For external use only

Purpose

Acne medication

Directions
  • wet face. Gently massage all over face for 20-30 seconds avoiding the eyes.   Rinse thoroughly and pat dry.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
  • if going outside, apply sunscreen after using this product.  If irritation or sensitivity develops stop use of both products and ask a doctor
  • Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas, during the first 3 days.  If no discomfort occurs, follow the directions stated above.
Other Information
  • keep tightly closed
  • store at room temperature (59⁰-77⁰)
Inactive Ingredients

water, cetyl alcohol, petrolatum, acrylates/C10-30 alkyl acrylate crosspolymer, zinc lactate, steareth-2, glycerin, potassium cetyl phosphate, xanthan gum, benzyl alcohol, fragrance, disodium EDTA, laureth-4, BHT, sodium hydroxide, lactic acid, menthol

Description

Benzoyl peroxide 10%

Principal Display Panel

amazon basics

daily

acne control

cleanser

10% Benzoyl Peroxide Acne Medication

Compare to Clean & Clear ®Continuous Control Acne Cleanser*

NET WT 5 OZ (141 g)

Use

for the treatment of acne

Disclaimer

*This product is not manufactured or distributed by the Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Continuous Control Acne Cleanser.

Do Not Use

if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Adverse Reaction

"Alexa, reoder Amazon Basics Acne Control Cleanser."

Distributed by:

Amazon.com Services LLC

Seattle, WA 98109

1-877-485-0385

2021 Amazon.com, Inc. or its afiliates.

All rights reserved

www.amazon.com/amazonbasics

Active Ingredient

Benzoyl peroxide 10%

When Using This Product
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleaced by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration
Stop Use and Ask A Doctor If

irritation becomes severe

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.  Avoid contact with eyes.  If contact occurs, flush thoroughly with water.


Structured Label Content

Warnings

For external use only

Purpose

Acne medication

Directions
  • wet face. Gently massage all over face for 20-30 seconds avoiding the eyes.   Rinse thoroughly and pat dry.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
  • if going outside, apply sunscreen after using this product.  If irritation or sensitivity develops stop use of both products and ask a doctor
  • Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas, during the first 3 days.  If no discomfort occurs, follow the directions stated above.
Other Information (Other information)
  • keep tightly closed
  • store at room temperature (59⁰-77⁰)
Inactive Ingredients (Inactive ingredients)

water, cetyl alcohol, petrolatum, acrylates/C10-30 alkyl acrylate crosspolymer, zinc lactate, steareth-2, glycerin, potassium cetyl phosphate, xanthan gum, benzyl alcohol, fragrance, disodium EDTA, laureth-4, BHT, sodium hydroxide, lactic acid, menthol

Principal Display Panel (principal display panel)

amazon basics

daily

acne control

cleanser

10% Benzoyl Peroxide Acne Medication

Compare to Clean & Clear ®Continuous Control Acne Cleanser*

NET WT 5 OZ (141 g)

Use

for the treatment of acne

Disclaimer

*This product is not manufactured or distributed by the Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Continuous Control Acne Cleanser.

Do Not Use (Do not use)

if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Adverse Reaction (ADVERSE REACTION)

"Alexa, reoder Amazon Basics Acne Control Cleanser."

Distributed by:

Amazon.com Services LLC

Seattle, WA 98109

1-877-485-0385

2021 Amazon.com, Inc. or its afiliates.

All rights reserved

www.amazon.com/amazonbasics

Active Ingredient (Active ingredient)

Benzoyl peroxide 10%

When Using This Product (When using this product)
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleaced by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation becomes severe

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.  Avoid contact with eyes.  If contact occurs, flush thoroughly with water.


Advanced Ingredient Data


Raw Label Data

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