BENZAC- salicylic acid gel 
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
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

                     Benzac Skin Refining Mask Carton

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERIN (UNII: PDC6A3C0OX)  
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
LEDIKITE (UNII: D7BC5B0F46)  
KAOLIN (UNII: 24H4NWX5CO)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
MONTMORILLONITE (UNII: A585MN1H2L)  
SANDALWOOD OIL (UNII: X7X01WMQ5F)  
SANDALWOOD (UNII: 3641YW25N2)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
WATER (UNII: 059QF0KO0R)  
ZINC SULFATE (UNII: 89DS0H96TB)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-3674-021 in 1 CARTON07/07/201508/28/2017
156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/01/201408/28/2017
Labeler - Galderma Laboratories, L.P. (047350186)

Revised: 11/2019
 
Galderma Laboratories, L.P.