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ANTIBACTERIAL MANDARIN

Dosage form: solution
Ingredients: TRICLOSAN 0.6mL in 100mL
Labeler: TOPCO ASSOCIATES L LLC
NDC Code: 36800-066

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 BOX

ACTIVE INGREDIENT

TRICLOSAN 0.6%

PURPOSE

ANTIBACTERIAL

USES

FOR WASHING TO HELP DECREASE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

IRRITATION OR RASH DEVELOPS AND LASTS.

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, VIGOROUSLY WORK INTO A LATHER AND RINSE THOROUGHLY.

INACTIVE INGREDIENTS

WATER, SODIUM XYLENESULFONATE, SODIUM LAURETH SULFATE, DIPROPYLENE GLYCOL, COCAMIDOPROPYL BETAINE, POLYSORBATE 20, FRAGRANCE, DISODIUM PHOSPHATE, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, YELLOW 5 (CI 19140), RED (CI 14700).

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 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM PHOSPHATE, DIBASIC 
ANHYDROUS CITRIC ACID 
FD&C RED NO. 4 
FD&C YELLOW NO. 5 
POLYSORBATE 20 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:36800-066-08222 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/23/2011
Labeler - TOPCO ASSOCIATES L LLC (006935977)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 08/2011
Document Id: 2705f5b5-d8ac-45c9-a50b-e52ff45dfb17
Set id: ead91019-f85c-4731-847a-076918f30872
Version: 2
Effective Time: 20110823
 
TOPCO ASSOCIATES L LLC

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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