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Benzac by Galderma Laboratories, L.P.

Medically reviewed on January 8, 2018

Dosage form: solution
Ingredients: SALICYLIC ACID .5g in 100mL
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 Balancing Foaming Cleanser

Active Ingredient........Purpose

Salicylic Acid 0.5%............Acne treatment

Use

• 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 irratation develops, discontinue use.»

Drug Facts (continued)

Directions

• wet face. Pump a small amount of cleanser onto wet palms. Gently massage the cleanser all over your face for about 20-30 seconsd, avoiding the eye area. Rinse thoroughly, then pat dry.

• because excesssive 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

Alcohol Denatured, Backhousia Citriodora Leaf Extract, Butylene Glycol, Caprylic/Capric Triglyceride, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Reticulate (Tangerine) Peel Oil, Glycerin, Glycine Soja (Soybean) Oil, Lauramidopropyl Betaine, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Phenoxyethanol, Polysorbate 80, Potassium Benzoate, Potassium Sorbate, Santalum Album (Sandalwood) Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Terminalia Ferdinandiana Fruit Extract, Tocopherol, Water

Questions or comments?

1-866-735-4137

Package

GALDERMA

BENZAC®

ACNE SOLUTIONS

Peel for Drug Facts

Skin Balancing Foaming Cleanser

With calming and soothing East Indian Sandalwood Oil

1 CLEANSE

0.5% Salicylic Acid

6 FL OZ (177 mL)

Skin Balancing Foaming Cleanser

is proven to gently exfoliate the skin, remove excess oil, and soothe breakouts without overdrying the skin. Instant foam minimizes irritation.

  • Dermatologist developed
  • Non-Comedogenic
  • Free of sulfates, artificial fragrance, dyes & preservatives

302993674061

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

Distributed by:

Galderma Laboratories, L.P.

Fort Worth TX 76177 USA

GALDERMA is a registered trademark

Made in USA

P52488-0

East Indian Sandalwood 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.

BENZAC 
salicylic acid solution
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 ACID.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
BACKHOUSIA CITRIODORA LEAF 
BUTYLENE GLYCOL 
MEDIUM-CHAIN TRIGLYCERIDES 
ANHYDROUS CITRIC ACID 
ORANGE OIL 
CITRUS MAXIMA FRUIT RIND OIL 
MANDARIN OIL 
GLYCERIN 
SOYBEAN OIL 
LAURAMIDOPROPYL BETAINE 
LONICERA CAPRIFOLIUM FLOWER 
LONICERA JAPONICA FLOWER 
PHENOXYETHANOL 
POLYSORBATE 80 
POTASSIUM BENZOATE 
POTASSIUM SORBATE 
SANDALWOOD OIL 
KAKADU PLUM 
TOCOPHEROL 
WATER 
Packaging
#Item CodePackage Description
1NDC:0299-3674-06177 mL in 1 BOTTLE, PUMP
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
Accupac, Inc.071609663manufacture(0299-3674)

 
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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