BENZAC - benzoyle peroxide solution 
Galderma Laboratories, L.P.

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.

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BENZAC® ACNE SOLUTIONS
Acne Eliminating Cleanser

Active Ingredient

Benzoyl Peroxide 2.6%

Purpose

Acne Treatment

Uses

  • For the treatment of acne
  • Penetrates pores to eliminate most acne blemishes and help prevent new ones from forming

Warnings

For external use only


Do not use if you: • Have very sensitive skin • Are sensitive to benzoyl peroxide

When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation 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 doctor if

• irritation becomes severe.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet face. Apply Acne Eliminating Cleanser and gently massage area for 1-2 minutes. Rinse thoroughly and pat dry. • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily as 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 irratation or sensitivity develops, stop use of both products and ask a doctor.

Inactive Ingredients

Citric acid monohydrate, Dipotassium Glycyrrhizate, Edetate disodium, Magnesium Aluminum Silicate, PEG-75, Phenoxyethanol, Poloxamer 124, Propylene Glycol, Purified Water, Silicia, Sodium C14-16, Olefin Sulfonate, Titanium Dioxide, Xanthan Gum, Zinc Gluconate

Questions of comments?

1-866-735-4137

                     Benzac Acne Eliminating Cleanser Tube

GALDERMA

BENZAC

ACNE SOLUTIONS

Acne Eliminating Cleanser

1 CLEANSE

2.6% Benzoyl Peroxide

6 FL OZ (177 mL)

Distributed By:

Galderma Laboratories, L.P.

Fort Worth, TX 76177 USA

GALDERMA is a registered trademark

Made in Canada

P52459-0

BENZAC  
benzoyle peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-3673
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLOXAMER 124 (UNII: 1S66E28KXA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-3673-05177 mL in 1 TUBE; Type 0: Not a Combination Product06/05/201505/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/201505/31/2017
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663manufacture(0299-3673)

Revised: 9/2017
 
Galderma Laboratories, L.P.