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Name:Antibacterial Refill
Manufacturer:Kmart Corporation
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ANTIBACTERIAL  REFILL - triclosan liquid 
KMART CORPORATION

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 0.15%

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 THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOPS.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

USE TO REFILL A HAND SOAP PUMP BOTTLE.  FROM THE PUMP BOTTLE APPLY A SMALL AMOUNT ONTO WET HANDS. LATHER AND RINSE CLEAN.

QUESTIONS OR COMMENTS

1-800-842-7886

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDROPROPYL BETAINE, SODIUM CHLORIDE, COCAMIDOPROPYL HYDROXYSULTAINE, GLYCERIN, FRAGRANCE, POLYQUATERNIUM-7, PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE, DMDM HYDANTOIN, TETRASODIUM EDTA, CITRIC ACID, YELLOW 5 (CI 19140), RED 4 (CI 14700).

IMAGE OF ANTIBACTERIAL


ANTIBACTERIAL   REFILL
triclosan liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49738-294
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 0.15 L  in 100 L
Inactive Ingredients
Ingredient Name Strength
WATER  
SODIUM LAURETH SULFATE  
COCAMIDOPROPYL BETAINE  
SODIUM CHLORIDE  
COCAMIDOPROPYL HYDROXYSULTAINE  
GLYCERIN  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)  
DMDM HYDANTOIN  
EDETATE SODIUM  
ANHYDROUS CITRIC ACID  
FD&C YELLOW NO. 5  
FD&C RED NO. 4  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49738-294-64 1.89 L in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/01/2011

Labeler - KMART CORPORATION (008965873)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture

Revised: 06/2011 KMART CORPORATION



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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