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Benzac by Galderma Laboratories, L.P.

Dosage form: gel
Ingredients: SALICYLIC ACID 0.5g in 100g
Labeler: Galderma Laboratories, L.P.
NDC Code: 0299-3674

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.

BENZAC® ACNE SOLUTIONS
Skin Refining Mask

Active Ingredient.....Purpose

Salicylic Acid 0.5%............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

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.

Stop use and ask a doctor if

• Irritation becomes severe.

Keep out of reach of children.

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

Do not use around eye area. If contact occurs, flush thoroughly with water. If irritation develops, discontinue use.

Directions

• Start with clean, dry skin. Massage tube before use. Apply all over face, avoiding the eyes and mouth. Allow to dry for 5 minutes then rinse thoroughly and pat dry.  Can be used 2-3 times per week.

• 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.

Inactive Ingredients

Anhydrous Citric Acid, Alcohol Denatured, Benzyl Alcohol, Glycerin, Glyceryl Caprylate, Hydrolyzed Algin, Illite, Kaolin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Montmorillonite, Polysorbate 80, Santalum Album (Sandalwood) Oil, Santalum Spicatum (Sandalwood) Powder, Terminalia Ferdinandiana Fruit Extract, Water, Zinc Sulfate

Questions or comments?

1-866-735-4137

Package

                    

GALDERMA

BENZAC®

ACNE SOLUTIONS

Skin Refining Mask

With calming and soothing East Indian Sandalwood Oil

+2 TREAT

0.5% Salicylic Acid

NET WT 2 OZ (56g)

From the makers of the world's leading branded topical acne prescription medication, Benzac Acne Solutions regimen is clinically proven to fight acne at its source and break the acne cycle.

Skin Refining Mask

is a clinically proven skin optimizing step that can be added to your regimen 2 to 3 times per week to remove excess oil and quickly reduce swelling and redness.

  • Dermatologist tested
  • Non-Comedogenic
  • Free of artificial fragrances and dyes

East Indian Sandalwood Oil is one of nature's rare and ancient healers. Now, sustainably grown in a rehabilitated forest, the oil is extracted using renewable energy, resulting in the world's only therapeutic grade of East Indian Sandalwood Oil.

This exceptional ingredient, which is reported to have gentle anti-bacterial and anti-inflammatory properties, is the secret to our clinically proven acne-fighting formulas, designed to help give you clear and healthy skin.

Distributed by:

Galderma Laboratories, L.P.

Fort Worth TX 76177 USA

GALDERMA is a registered trademark

P52486-1

BENZAC 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-3674
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
ALCOHOL 
BENZYL ALCOHOL 
GLYCERIN 
Glyceryl Monocaprylate 
SODIUM ALGINATE 
LEDIKITE 
KAOLIN 
LONICERA CAPRIFOLIUM FLOWER 
LONICERA JAPONICA FLOWER 
MONTMORILLONITE 
SANDALWOOD OIL 
SANDALWOOD 
KAKADU PLUM 
WATER 
ZINC SULFATE 
POLYSORBATE 80 
Packaging
#Item CodePackage Description
1NDC:0299-3674-021 TUBE in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/01/2014
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIOperations
Ei, LLC105803274manufacture(0299-3674)

Revised: 07/2015
 
Galderma Laboratories, L.P.

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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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