BENZAC- salicylic acid solution

Benzac by

Drug Labeling and Warnings

Benzac by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

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

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.»

DOSAGE & ADMINISTRATION

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.

INGREDIENTS AND APPEARANCE

BENZAC 
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-3674
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-3674-06	177 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2014

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	manufacture(0299-3674)