CARE ONE ANTIBACTERIAL RUM RAISIN- 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

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

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.

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM LAURETH SULFATE, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYLAMINE OXIDE, GLYCERIN, SODIUM CHLORIDE, PEG-7 GLYCERYL COCOATE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, TETRASODIUM EDTA, PROPYLENE GLYCOL, POLYSORBATE 60, ALOE BARBADENSIS LEAF JUICE, BENZOPHENONE-4, HYDROXYPROPYL METHYLCELLULOSE, CARAMEL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

IMAGE OF THE LABEL

CARE ONE  ANTIBACTERIAL RUM RAISIN
triclosan liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-190
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 (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SULISOBENZONE (UNII: 1W6L629B4K)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CARAMEL (UNII: T9D99G2B1R)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-190-08 237 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(41520-190)

Revised: 9/2012
Document Id: ca40d723-dbc2-4b81-b176-03f1e6f15333
Set id: a8861ec4-0f48-40ea-b005-2d83222932b0
Version: 1
Effective Time: 20120927
 
AMERICAN SALES COMPANY