FREDS ANTIBACTERIAL FRESH PEAR- triclosan liquid 
FREDS 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 0.46%

PURPOSE

ANTIBACTERIAL

USES

HELPS REDUCE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

STOP USING THIS PRODUCT AND ASK DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

APPLY ONTO DRY HANDS. WORK INTO A RICH FOAMY LATHER, RINSE AND DRY THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM XYLENESULFONATE, DIPROPYLENE GLYCOL, GLYCERIN, SODIUM PCA, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, POLYQUATERNIUM-10, FRAGRANCE (PARFUM), DISODIUM PHOSPHATE, CETYL ALCOHOL, ALOE BARBADENSIS LEAF JUICE, CITRIC ACID, METHYLPARABEN, PROPYLPARABEN, GREEN 3 (CI 42053), YELLOW (CI 47005).

IMAGE OF THE LABEL

FREDS  ANTIBACTERIAL FRESH PEAR
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-185
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.46 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-185-08222 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/25/2012
Labeler - FREDS INC. (005866116)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55315-185)

Revised: 9/2012
Document Id: c6aa50b8-8560-480f-8af5-6cce5e883904
Set id: ac8fa8b0-74af-421e-88a4-9cfe38a03bf4
Version: 1
Effective Time: 20120925
 
FREDS INC.