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ANTIBACTERIAL by FRED'S INC

Dosage form: liquid
Ingredients: TRICLOSAN 0.115mL in 100mL
Labeler: FRED'S INC
NDC Code: 55315-720

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.

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).

ANTIBACTERIAL  
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-720
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN0.115 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
DECYL GLUCOSIDE 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) 
PEG-7 GLYCERYL COCOATE 
PEG-120 METHYL GLUCOSE DIOLEATE 
EDETATE SODIUM 
SODIUM CHLORIDE 
DMDM HYDANTOIN 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
D&C RED NO. 33 
SODIUM SULFATE 
POLOXAMER 124 
Packaging
#Item CodePackage Description
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/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 07/2011
 
FRED'S INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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