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Benzac by Galderma Laboratories, L.P.

Medically reviewed on January 12, 2018

Dosage form: gel
Ingredients: SALICYLIC ACID 2g in 100mL
Labeler: Galderma Laboratories, L.P.
NDC Code: 0299-3677

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
Intensive Spot Treatment

Active Ingredient..Purpose

Salicylic Acid 2%....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

• clean the skin thoroughly before applying this product

• cover the entire affected area with a thin layer once or twice daily

• because 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.»

Drug Facts (continued)

Inactive Ingredients

Alcohol, Allium Fistulosum Bulb Extract, Backhousia Citriodora Leaf Extract, Butylene Glycol, Butylparaben, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid, Echium Plantagineum Seed Oil, Ethylparaben, Hamamelis Virginiana (Witch hazel) Water, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Hydroxypropylcellulose, Isobutylparaben, Methylparaben, Octyldodecanol, Phenoxyethanol, Potassium Benzoate, Potassium Sorbate, Propylparaben, Santalum Album (Sandalwood) Oil, SD Alcohol 40-B, Tocopherol, Water

Questions or comments?

1-866-735-4137

Package

GALDERMA

BENZAC®

ACNE SOLUTIONS

Intensive Spot Treatment

With calming and soothing East Indian Sandalwood Oil

2 TREAT

2% Salicylic Acid

0.5 FL OZ (14 mL)

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.

Intensive Spot Treatment

is clinically proven to rapidly clear and calm inflamed, blemished skin.

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

East Indian Sandalwood Oil is one of nature's rare and ancient healers. Reported to have antibacterial and anti-inflammatory properties, it is the secret to our acne fighting formulas.

302993674054

Distributed by:

Galderma Laboratories, L.P.

Fort Worth TX 76177 USA

GALDERMA is a registered trademark

Made in USA

P52494-0

BENZAC 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-3677
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ALLIUM FISTULOSUM BULB 
BACKHOUSIA CITRIODORA LEAF 
BUTYLENE GLYCOL 
BUTYLPARABEN 
CARDIOSPERMUM HALICACABUM FLOWERING TOP 
ANHYDROUS CITRIC ACID 
ECHIUM PLANTAGINEUM SEED OIL 
ETHYLPARABEN 
HAMAMELIS VIRGINIANA TOP WATER 
SUNFLOWER OIL 
HYDROXYPROPYL CELLULOSE (TYPE H) 
ISOBUTYLPARABEN 
METHYLPARABEN 
OCTYLDODECANOL 
PHENOXYETHANOL 
POTASSIUM BENZOATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
SANDALWOOD OIL 
TOCOPHEROL 
WATER 
Packaging
#Item CodePackage Description
1NDC:0299-3677-001 TUBE in 1 CARTON
114 mL 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(0299-3677)

 
Galderma Laboratories, L.P.

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Further information

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