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Name:Antibacterial
Manufacturer:Hyvee Inc
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

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 0.115%

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 WITH WATER.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

IRRITATION AND REDNESS DEVELOP.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

PUMP ONTO WET HANDS. WORK INTO A LATHER RINSE THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, FRAGRANCE, DMDM HYDANTOIN, SODIUM CHLORIDE, PEG-120 METHYL GLUCOSE DIOLEATE, TETRASODIUM EDTA, SODIUM SULFATE, POLYQUATERNIUM-7, CITRIC ACID, POLOXAMER 124, PEG- 7 GLYCERYL COCOATE, RED 33 (CI 17200,  BLUE 1 (CI 42090).

IMAGE OF ANTIBACTERIAL


ANTIBACTERIAL  
triclosan liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-720
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 0.115 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
SODIUM LAURETH SULFATE  
COCAMIDOPROPYL BETAINE  
DECYL GLUCOSIDE  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)  
GLYCERYL COCOATE  
PEG-120 METHYL GLUCOSE DIOLEATE  
EDETATE SODIUM  
SODIUM CHLORIDE  
DMDM HYDANTOIN  
CITRIC ACID MONOHYDRATE  
FD&C BLUE NO. 1  
D&C RED NO. 33  
SODIUM SULFATE  
POLOXAMER 124  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42507-720-08 222 mL in 1 BOTTLE, PUMP None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/09/2011

Labeler - HYVEE INC (006925671)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture

Revised: 06/2011 HYVEE INC



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


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