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Benzac by Galderma Laboratories, L.P.

Dosage form: solution
Ingredients: SALICYLIC ACID .5g in 100mL
Labeler: Galderma Laboratories, L.P.
NDC Code: 0299-3676

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
Blemish Clearing Hydrator

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

Do not use

• on damaged skin (cuts, abrasions, eczema, sunburned)

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 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.»

Drug Facts (continued)

Inactive Ingredients

Alcohol Denatured, Backhousia Citriodora Leaf Extract, Butyl Avocadate, Butylene Glycol, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Chlorphenesin, Citric Acid, Glycerin, Hydrolyzed Algin, Isodecyl Neopentanoate, Laureth-7, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Methylparaben, Phenoxyethanol, Polyacrylamide, Potassium Benzoate, Potassium Sorbate, Propylene Glycol, Santalum Album (Sandalwood) Oil, Terminalia Ferdinandiana Fruit Extract, Water, Zinc Sulfate

Questions or comments?

1-866-735-4137

Package

                    

GALDERMA

BENZAC®

ACNE SOLUTIONS

Blemish Clearing Hydrator

With calming and soothing East Indian Sandalwood Oil

3 HYDRATE

0.5% Salicylic Acid

1FL OZ (29 mL)

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.

Blemish Clearing Hydrator

is a lightweight formula which controls excess oil and hydrates the 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 anti-bacterial and anti-inflammatory properties, it is the secret to our acne fighting formulas.

302993674030

Distributed by:

Galderma Laboratories, L.P.

Fort Worth TX 76177 USA

GALDERMA is a registered trademark

Made in USA

P52491-0

BENZAC 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-3676
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 
C13-14 ISOPARAFFIN 
MEDIUM-CHAIN TRIGLYCERIDES 
CHLORPHENESIN 
ANHYDROUS CITRIC ACID 
GLYCERIN 
ISODECYL NEOPENTANOATE 
LAURETH-7 
LONICERA CAPRIFOLIUM FLOWER 
LONICERA JAPONICA FLOWER 
METHYLPARABEN 
PHENOXYETHANOL 
POLYACRYLAMIDE (10000 MW) 
POTASSIUM BENZOATE 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
SANDALWOOD OIL 
KAKADU PLUM 
WATER 
ZINC SULFATE 
Packaging
#Item CodePackage Description
1NDC:0299-3676-001 BOTTLE, PUMP in 1 CARTON
129 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(0299-3676)

 
Galderma Laboratories, L.P.

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Medically reviewed on Jan 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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