CARE ONE ANTIBACTERIAL TANGERINE SPICE- triclosan liquid
AMERICAN SALES COMPANY

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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DRUG FACTS

ACTIVE INGREDIENT

TRICLOSAN 0.3%

PURPOSE

ANTIBACTERIAL

USES

FOR WASHING TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

STOP USING THIS PRODUCT AND ASK DOCTOR

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

APPLY TO DRY HANDS, WORK INTO A RICH FOAMY LATHER AND RINSE THOROUGHLY.

WATER, SODIUM XYLENESULFONATE, GLYCERIN, DIPROPYLENE GLYCOL, COCAMIDOPROPYL BETAINE, SODIUM LAURETH SULFATE, DISODIUM PHOSPHATE, FRAGRANCE (PARFUM), METHYLPARABEN, PROPYLPARABEN, POLYSORBATE-20, SODIUM PCA, POLYQUATERNIUM-10, TOCOPHERYL ACETATE, CITRIC ACID, CETYL ALCOHOL, RED 33 (CI 17200), ORANGE 4 (CI 15510).

LABEL COPY

IMAGE OF THE LABEL

CARE ONE ANTIBACTERIAL TANGERINE SPICE
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-191
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER BUFFALO (UNII: 0A4PW6CRAI)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CETYL ALCOHOL (UNII: 936JST6JCN)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-191-08	237 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/27/2012

Labeler - AMERICAN SALES COMPANY (809183973)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(41520-191)