Equate Repairing
FDA Label NDC 49035-020

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Equate Repairing (NDC 49035-020). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient                                     PurposeBenzoyl Peroxide, 2.5%.......................................Acne Treatment

Otc - Purpose

Use - for the management of acne

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a PoisonControl Center right away.

Indications & Usage


Directions

- cleanse the skin thoroughly before applying medication.
- cover the entire affected area with a thin film 1-3 times daily
- because excessive drying of the skin may occur, start with 1 application daily and then increase to 2 or 3 times if needed or as directed by a doctor.
- if bothersome drying or peeling occurs, reduce application to once a day or every other day
- if going outside, use a sunscreen

Other Information

- this product may bleach hair or dyed fabrics
- avoid storing at extreme temperatures (below 40 degrees F and above 100 degrees F)

Warnings

Warnings For external use only. Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following the use of this product.This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.When using this product- avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water- Keep away from lips and mouth- Avoid unnecessary sun exposure and use a sunscreenStop use and ask a doctor if skin irritation occurs.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration


Directions

- cleanse the skin thoroughly before applying medication.
- cover the entire affected area with a thin film 1-3 times daily
- because excessive drying of the skin may occur, start with 1 application daily and then increase to 2 or 3 times if needed or as directed by a doctor.
- if bothersome drying or peeling occurs, reduce application to once a day or every other day
- if going outside, use a sunscreen

Other Information

- this product may bleach hair or dyed fabrics
- avoid storing at extreme temperatures (below 40 degrees F and above 100 degrees F)

Inactive Ingredient

Inactive Ingredients purified water, cetearyl alcohol, ceteraeth-20, ethoxydiglycol, cyclotetrasilozane, propylene glycol, dimethicone,glyceryl stearate, cyclopentasiloxane, diazolidinyl urea, methylparaben, propylparaben, PEG-100 stearate, panthenol, allantonin, triethanolamine,carbomer, fragrance, xanthan gum

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