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Benzoyl Peroxide by GERITREX LLC

Medically reviewed on August 10, 2018

Dosage form: gel
Ingredients: BENZOYL PEROXIDE 10g in 100g
Labeler: GERITREX LLC
NDC Code: 54162-019

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Benzoyl Peroxide Gel

Drug Facts

Active Ingredient Purpose

Benzoyl Peroxide 10% Acne Treatment

Use

For the treatment of acne

Directions

Shake well, wet face, apply to hands, add water, work into a lather, and massage gently onto face. Rinse thoroughly and pat dry

use 2 to 3 times daily or as directed by a doctor if bothersome dryness of peeling occurs, reduce application to once a day or every other

day if going outside use sunscreen. After washing and drying face follow directions in the sunscreen labeling if irritation or sensitivity develops,

discontinue use of both products and consult a doctor

Warnings

For external use only

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

When using this product avoid unnecessary sun exposure and use a sunscreen using other topical acne drugs at the same time or right

after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a

doctor. Irritation may develop, such as redness, burning, itching, peeling, or possibly swelling more frequent use or higher concentraions may

aggravate such irritation: mild irritation may be reduced by using the product less frequently or in lower concnetraion. Keep away from eyes,

lips, mouth It may bleach hair of dye fabrics

Stop use and ask a doctor if irritaion becomes severe and continue.

Inactive Ingrdients

Purified water, Carbomer, Cetearth 20 cetearyl alcohol, DMDM Hydantoin, EDTA, Peg 40 Hydrogenated castor oil, Ethyl Glycol Mono Stearate, Mineral Oil, Methyl and Propyl Paraben, Peg 200 dilurate, Glycerin, silicon oil, Stearic acid, stearyl alcohol, TEA, Magnesium aluminium silicate powder

Keep out of reach of chlidren. If swallowed, get medical help or contact Poison Control Center right away

Store at room temperature 15°-30°C (59°-86°F)

Use 2 to 3 times daily or as directed by a doctor.

BENZOYL PEROXIDE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-019
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER 940 
CETYL ALCOHOL 
DMDM HYDANTOIN 
MAGNESIUM DISODIUM EDTA 
PEG-40 CASTOR OIL 
MINERAL OIL 
METHYLPARABEN 
PROPYLPARABEN 
PEG-200 DILAURATE 
GLYCERIN 
SILICON 
STEARIC ACID 
STEARYL ALCOHOL 
TRIETHANOLAMINE LAURYL SULFATE 
MAGNESIUM ALUMINUM SILICATE 
DIETHYLENE GLYCOL DISTEARATE 
DISODIUM HEDTA 
Packaging
#Item CodePackage Description
1NDC:54162-019-0256 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/31/2015
Labeler - GERITREX LLC (112796248)
Registrant - GERITREX LLC (112796248)
Establishment
NameAddressID/FEIOperations
GERITREX LLC112796248manufacture(54162-019)

 
GERITREX LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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