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Benzoyl Peroxide 5% Gel

Dosage form: gel
Ingredients: BENZOYL PEROXIDE 50mg in 1000mg
Labeler: Axia Medical Solutions, LLC
NDC Code: 68723-305

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.

Dermesse Benzoyl Peroxide 5% Gel

Active Ingredient:

Benzoyl Peroxide 5%

Purpose

Acne Treatment

USES:

For the treatment of acne.

WARNINGS:

For external use only.

Do not use if you:

• Have sensitive skin. • Are sensitive to benzoyl peroxide.

When using the product:

• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If this occurs only use one topical acne medication at a time • Avoid unnecessary sun exposure and use a sunscreen • Avoid contact with the eyes, lips, and mouth • 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.

Stop use and ask a doctor if:

Irritation become severe.

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 • 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 • 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:

Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Panthenol, PEG-8, PEG-14 Palmeth-60 Hexyl Dicarbamate, Sodium Hyaluronate, Triethanolamine, and Water.

OTHER INFORMATION:

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

Questions?:

866-494-4466, Mon-Fri 8:00AM-5:00PM

Dist. By Axia Medical Solutions, 2105 Camino Vida Roble, Carlsbad, Ca. 92011

www.dermesse.com     866-494-4466 office, 760-931-8267 fax

BENZOYL PEROXIDE 5% GEL 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68723-305
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE50 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALOE VERA LEAF 
BENZYL ALCOHOL 
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
EDETATE DISODIUM 
DISODIUM LAURETH SULFOSUCCINATE 
GLYCERIN 
PANTHENOL 
POLYETHYLENE GLYCOL 400 
PPG-14 PALMETH-60 HEXYL DICARBAMATE 
HYALURONATE SODIUM 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:68723-305-0257 mg in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/18/2017
Labeler - Axia Medical Solutions, LLC (929224694)

Revised: 07/2017
 
Axia Medical Solutions, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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