ANTIBACTERIAL MANDARIN - triclosan solution 
TOPCO ASSOCIATES L LLC

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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ACTIVE INGREDIENT

TRICLOSAN 0.6%

PURPOSE

ANTIBACTERIAL

USES

HELPS REDUCE 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 OR CONTACT POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

PUMP ONTO DRY HANDS. WORK INTO A LATHER AND RINSE THOROUGHLY

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), SODIUM XYLENESULFONATE, DIPROPYLENE GLYCOL, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAMINE, FRAGRANCE (PARFUM), DISODIUM PHOSPHATE, CITRIC ACID, RED 4 (CI 14700), YELLOW 5 (CI 19140)

LABEL COPY

image of the label


ANTIBACTERIAL  MANDARIN
triclosan solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-066
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN0.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM XYLENESULFONATE 
DIPROPYLENE GLYCOL 
AMMONIUM LAURYL SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM PHOSPHATE, DIBASIC 
ANHYDROUS CITRIC ACID 
FD&C RED NO. 4 
FD&C YELLOW NO. 5 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:36800-066-08222 mL in 1 BOTTLE, PUMPNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/05/2011

Labeler - TOPCO ASSOCIATES L LLC (006935977)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 08/2011 TOPCO ASSOCIATES L LLC