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 TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-190
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-190-08237 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/27/2012
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(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