SALICYLIC ACID by Greenbrier International, Inc. / Lab Douce Cosmetics (Shenzhen) Co., Ltd. ACNE WASH

SALICYLIC ACID by

Drug Labeling and Warnings

SALICYLIC ACID by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., Lab Douce Cosmetics (Shenzhen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SALICYLIC ACID- salicylic acid liquid 
Greenbrier International, Inc.

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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ACNE WASH

Drug Facts

Active Ingredients

Salicylic acid ............. 2%

Purpose

Acne Treatment

Uses

• For the management of acne

Warnings

For external use only

Avoid contact with eyes, if contact occurs, flush thoroughly with water.

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.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• use twice daily
• apply water to face and hands
• dispense our Oil Free Acne Wash into hands and lather
• apply to face, nose area and neck and gently massage into skin
• rinse thoroughly with tepid water

Other information

• store at 20 oC-25 oC (68 oF to 77 oF)

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Chamomilla Recutita (Matricaria) Flower Extract, Cacamidopropyl PG-Dimonium Chloride Phosphate, Propylene Glycol, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Lactate, PEG-80 Sorbitan Laurate, Disodium EDTA, Benzalkonium Chloride, Fragrance, Yellow 5, Red 40

Distributed By

GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 MADE IN CHINA

OIL-FREE ACNE WASH 236mL

Product Label

SALICYLIC ACID 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-8885
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
CHAMOMILE (UNII: FGL3685T2X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-8885-1	236 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2017	12/31/2019

Labeler - Greenbrier International, Inc. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
Lab Douce Cosmetics (Shenzhen) Co., Ltd.		529303186	manufacture(33992-8885)

Revised: 12/2019

Document Id: 9a98692a-cdd7-e825-e053-2995a90a812b

34390-5

Set id: 5e3ad770-e41f-f80a-e053-2a91aa0a94dc

Version: 6

Effective Time: 20191226

 

Greenbrier International, Inc.