ANTIBACTERIAL  - triclosan liquid 
FRED'S INC

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 0.115%

PURPOSE

ANTIBACTERIAL

USES

HELPS ELIMINATE GERMS ON HANDS.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOP.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

APPLY ONTO WET HANDS, LATHER, AND RINSE.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, SODIUM CHLORIDE, FRAGRANCE, DMDM HYDANTOIN, PEG-120 METHYL GLUCOSE DIOLEATE, TETRASODIUM EDTA, SODIUM SULFATE, POLYQUATERNIUM-7, CITRIC ACID, POLOXAMER 124, PEG- 7 GLYCERYL COCOATE, RED 33 (CI 17200), BLUE 1 (CI 42090).

image of label

ANTIBACTERIAL  
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-720
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.115 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
POLOXAMER 124 (UNII: 1S66E28KXA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-720-08222 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/26/2011
Labeler - FRED'S INC (005866116)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 7/2011
Document Id: 903905b0-dd10-47b3-bd02-428ba3a66026
Set id: c03a5dd7-5194-4a3d-bea5-9dc63e2da2f0
Version: 1
Effective Time: 20110726
 
FRED'S INC