Anti-Blemish Cleanser by Bicooya Cosmetics Limited

Anti-Blemish Cleanser by

Drug Labeling and Warnings

Anti-Blemish Cleanser by is a Otc medication manufactured, distributed, or labeled by Bicooya Cosmetics Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTI-BLEMISH CLEANSER- salicylic acid cream 
Bicooya Cosmetics Limited

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.

----------

Active ingredients

Salicylic acid ............. 0.5%

Purpose

Acne Treatment

Use

• for the reatment of acne.

warnings

For external use only.

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

When using this product and other topical acne

• medication at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only use one medication should be used unless directed by a doctor.

Keep out of reach of children

if swalloed, get mediacl help or contact a Poison Control Center right away. Avoid contact with eyes, if contact ouccurs, rinse thoroughly with water.

Directions

• use daily.
• wet face, squeeze into hands and apply to face
• massage facde gently
• rinse thoroughly with water

Inactive ingredients

water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, disodium cocoamphodiacetate, sodium C12-15 pareth-15 sulfonate, aloe barbadensis leaf extract, anthemis nobilis flower extract, matricaria (chamomilla recutita) flower extract, linoleamidopropyl PG-dimonium chloride phosphate, disodium EDTA, propylene glycol, yellow 5, red 40 , sodium chloride, fragrance

Principal Display Panel

Acne Body Wash

• for clear and smooth skin
• Salicylic Acid helps prevent and treat blemishes

ANTI-BLEMISH CLEANSER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58180-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic acid	14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM C12-15 PARETH-15 SULFONATE (UNII: 353VA59XH8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CHAMOMILE (UNII: FGL3685T2X)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58180-105-01	142 g in 1 TUBE; Type 0: Not a Combination Product	12/16/2014	04/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/16/2014	04/08/2020

Labeler - Bicooya Cosmetics Limited (421310774)

Registrant - Bicooya Cosmetics Limited (421310774)

Establishment
Name	Address	ID/FEI	Business Operations
Bicooya Cosmetics Limited		421310774	manufacture(58180-105)

Revised: 4/2020

Document Id: ae40f621-3ef4-4d8b-9cb1-412657d9fc72

34390-5

Set id: 53fef70c-b8ed-4dad-a577-c90f05a0c94c

Version: 10

Effective Time: 20200408

 

Bicooya Cosmetics Limited