FOAMING ANTIBACTERIAL - triclosan liquid 
HYVEE 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 0.6%


Purpose

Antibacterial

Uses

For hand 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 if

Irritation and redness develop.

Keep out of reach of children

In case of accidental ingestion, get medical help and contact Poison Control Center immediately.

Directions

Pump onto dry hands, work into a lather and rinse thoroughly.

INACTIVE INGREDIENTS

WATER, SODIUM XYLENE SULFONATE, DIPROPYLENE GLYCOL, GLYCERIN, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, FRAGRANCE, DISODIUM PHOSPHATE, CITRIC ACID, RED 4 (CI 14700), YELLOW 5 (CI 19140).

IMAGE OF FOAMING ANTIBACTERIAL

FOAMING ANTIBACTERIAL 
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-178
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.46 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-178-08222 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/09/2011
Labeler - HYVEE INC (006925671)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 6/2011
Document Id: 2aeb1a9a-d762-447a-9467-1246ef119f07
Set id: 7c7d992a-abff-44e3-abe9-ccf3fad0425c
Version: 1
Effective Time: 20110609
 
HYVEE INC