Signature Care Acne Medication Gel
FDA Label NDC 21130-730

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Signature Care Acne Medication (NDC 21130-730). 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 active ingredient, purpose, uses, warnings, otc - do not use, when using this product, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Uses

for the treatment of acne

Warnings

For external use only

Otc - Do Not Use

Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide 

When Using This Product

  • avoid contact with the eyes, lips, and mouth
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with hair and dyed fabrics which may be bleached 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.
  • 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.

Otc - Ask Doctor

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.

Directions

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Becasue 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 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.

Inactive Ingredients

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

Package Label.Principal Display Panel

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

1 OZ (28.3g)

NDC 21130-730-16

Label (Label)

Label (Label)

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

BLISTER PACK

NDC 21130-730-17

Carton (Carton)

Carton (Carton)

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