Benzoyl Peroxide
FDA Label NDC 49035-021

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 Benzoyl Peroxide (NDC 49035-021). 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

Purifying CleanserActive ingredient                      PurposeBenzoyl Peroxide 2.5%..............Acne Treatment
Repairing LotionActive ingredient                      PurposeBenzoyl Peroxide 2.5%..............Acne Treatment

Otc - Purpose

Purifying CleanserActive ingredient                      PurposeBenzoyl Peroxide 2.5%..............Acne TreatmentUse for the management of acne
Repairing LotionActive ingredient                      PurposeBenzoyl Peroxide 2.5%..............Acne TreatmentUse for the management of acne

Otc - Keep Out Of Reach Of Children

Purifying Cleanser Warning SectionWarningsFor external use onlyDo not use this medication if you have very sensitiveskin or if you are very sensitive to benzoyl peroxide.Ask a doctor or pharmacist before use if you areusing  other topical acne medications at the sametime or immediately following use of this product.This may increase dryness or irritation of the skin.If this occurs, only one medication should be usedunless 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- aviod unnecessary sun exposure and use a sunscreenStop use and ask a doctor if skin irritation occurs.Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Repairing Lotion Warning SectionWarnings For external use only Do not use this medication if you have very sensitive skin or if you are very 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 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 - aviod unnecessary sun exposure and use a sunscreenStop use and ask a doctor if skin irritation occurs. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Purifying Cleanser Directions Section

Directions

- Use morning and night. Apply a small (dime sized)
amount to dampened skin and gently massage for
1 to 2 minutes.
- Rinse thoroughly with warm water
- Pat dry
- If bothersome dryness 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)

Repairing Lotion Directions Section

Directions

- Cleanse the skin thoroughly before applying
medication
- Cover the entire affected area with a thin layer 1 to
3 times daily
- Because excessive drying of the skin may occur,
start with 1 application daily, then gradually
increase to 2 or 3 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, 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

Purifying Cleanser Warning SectionWarningsFor external use onlyDo not use this medication if you have very sensitiveskin or if you are very sensitive to benzoyl peroxide.Ask a doctor or pharmacist before use if you areusing  other topical acne medications at the sametime or immediately following use of this product.This may increase dryness or irritation of the skin.If this occurs, only one medication should be usedunless 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- aviod unnecessary sun exposure and use a sunscreenStop use and ask a doctor if skin irritation occurs.Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Repairing Lotion Warning SectionWarnings For external use only Do not use this medication if you have very sensitive skin or if you are very 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 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 - aviod unnecessary sun exposure and use a sunscreenStop use and ask a doctor if skin irritation occurs. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Purifying Cleanser Directions Section

Directions

- Use morning and night. Apply a small (dime sized)
amount to dampened skin and gently massage for
1 to 2 minutes.
- Rinse thoroughly with warm water
- Pat dry
- If bothersome dryness 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)



Repairing Lotion Directions Section

Directions

- Cleanse the skin thoroughly before applying
medication
- Cover the entire affected area with a thin layer 1 to
3 times daily
- Because excessive drying of the skin may occur,
start with 1 application daily, then gradually
increase to 2 or 3 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, 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

Purifying Cleanser inactive ingredients sectionInactive Ingredientspurified water, disodium PEG-12 dimethiconesulfosuccinate, magnesium aluminum silicate,gyyceryl stearate, tridecyl stearate, neopentylglycol dicaprylate/dicaprate, tridecyl trimelliate,PEG-100 Stearate, sorbitol, dimethyl isosorbide,polyethylene, cetyl esters, anthemis nobilis flower extract, xanthan gum, propylene glycol,imidazolidinyl urea, sodium hyaluronate, sodiumPCA, methylparaben, propylparaben, fragrance
Repairing Lotion inactive ingredients sectionInactive ingredientspurified water, cetearyl alcohol, ceteareth-20,ethoxydiglycol, cyclotetrasiloxane, propyleneglycol, dimethicone, glyceryl stearate,cyclopentasiloxane diazolidinyl urea, methylparaben,propylparaben, PEG-100 stearate, panthenol,allantoin, triethanolamine, carbomer, fragrance,xanthan gum

* Please review the disclaimer below.