BENZAC - salicylic acid solution 
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 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

                     Benzac Skin Balancing Foaming Cleanser Front Label

Benzac Skin Balancing Foaming Back Label

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:0299-3675
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ORANGE OIL (UNII: AKN3KSD11B)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
MANDARIN OIL (UNII: NJO720F72R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOYBEAN OIL (UNII: 241ATL177A)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM BENZOATE (UNII: 763YQN2K7K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SANDALWOOD OIL (UNII: X7X01WMQ5F)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-3675-00177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/13/201510/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/13/201510/31/2017
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663manufacture(0299-3675)

Revised: 9/2017
 
Galderma Laboratories, L.P.