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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-191-08 237 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/27/2012
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Business Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(41520-191)

Revised: 9/2012
Document Id: 58455c76-6876-4299-82d7-1f859ad77b84
Set id: 63bd6f0e-8e5a-49ff-b853-a5b9a803632e
Version: 1
Effective Time: 20120927
 
AMERICAN SALES COMPANY