ANTIBACTERIAL MANDARIN AND POMELO- 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 0.15%

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 WITH WATER.

STOP USE AND ASK A DOCTOR IF

IF IRRITATION OR REDNESS DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

PUMP ONTO WET HANDS, WORK INTO A LATHER AND RINSE THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, PEG-120 METHYL GLUCOSE DIOLEATE, POLYQUATERNIUM-7, CITRUS GRANDIS (POMELO) EXTRACT, CITRUS NOBILIS (MANDARIN) FRUIT EXTRACT, PEG-7 GLYCERYL COCOATE, FRAGRANCE (PARFUM), PEG-40 HYDROGENATED CASTOR OIL, TETRASODIUM EDTA, DMDM HYDANTOIN, CITRIC ACID, SODIUM CHLORIDE, YELLOW 5 (CI 19140), RED 4 (CI 14700), RED 33 (CI 17200).

IMAGE OF C1

ANTIBACTERIAL  MANDARIN AND POMELO
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-293
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
PUMMELO (UNII: ET1TN5W71X)  
CITRUS NOBILIS (UNII: 8MFF77J91V)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-293-08236 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2011
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 4/2011
Document Id: 084b5ccb-cd0b-4afe-937f-609808367609
Set id: 15817b59-5471-4ccb-abe1-5777bd66b706
Version: 1
Effective Time: 20110401
 
AMERICAN SALES COMPANY