Family Care Acne Treatment
FDA Label NDC 65923-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Acne Treatment (NDC 65923-006). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                               Purpose

Benzoyl Peroxide 10%......................................................................Acne medications

Otc - Purpose

Uses

  • for the treatment and prevention of acne pimples

Warnings

Warnings

  • for external use only

Otc - Do Not Use

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

Otc - When Using

When using this product

  • avoid contact with eyes, lips and mouth
  • avoid contact with hair or dyed fabrics including carpet and clothing which may be bleached by this product
  • with other tropical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur.  If this occurs, only one medications should be use unless directed by a doctor
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling.  More frequent use or concentration may aggravate skin irritation.  Mild irritation may be reduced by using the product less frequently or in a lower concentration.

Otc - Stop Use

Stop use and ask a doctor if skin irritation becomes severe

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Indications & Usage

Directions

  • cleanse the skin thoroughly before applying medication
  • cover the entire affected area with a thin layer one to three times a day
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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
  • use to prevent new pimples from forming

Storage And Handling

Other information

  • keep tightly closed
  • keep away from heat

Inactive Ingredient

Inactive ingredients

bentonite, benzoyl peroxide, dimethicone, dried aluminum hydroxide gel, glyceryl stearate SE, isopropyl myristate, methylparaben, PEG-400, petrolatum, propylene glycol, propylparaben, tefose 63, water

Dosage & Administration

Distributed by: Consumer Care Products Corp.

                      Cerritos, CA 90703 USA

Made in Korea

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