Cvs Health Maximum Strength Acne Treatment
FDA Label NDC 69842-637

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Health for the product Cvs Health Maximum Strength Acne Treatment (NDC 69842-637). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Otc - Do Not Use

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Otc - When Using

When using this product

  • keep away from eyes, lips and mouth
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
  • using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Otc - Stop Use

Stop use and ask a doctor if

  • irritation becomes severe

Otc - 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 the eyes. If contact occurs, flush thoroughly with water.

Directions

  • cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

Keep tightly closed. Store at room temperature.

Inactive Ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Principal Display Panel - 28 G Tube Carton

CVSHealth™

Compare to the active ingredient
in Clean & Clear® persa-gel® 10*

MAXIMUM STRENGTH

Acne Treatment
Gel

10% BENZOYL PEROXIDE
ACNE MEDICATION

NET WT 1 OZ (28 g)

Not Actual Size

Principal Display Panel (28 g Tube Carton)

Principal Display Panel (28 g Tube Carton)

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