Label: ANTISEPTIC FOAM HANDWASH- chlorhexidine gluconate 2% solution liquid
- NDC Code(s): 21749-461-89
- Packager: GOJO Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 24, 2018
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- Active Ingredient/ Ingrédient Actif
- Purpose
- Indications
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Directions/Mode D'emploi
Wet hands. Apply an adequate amount of soap and work into a rich lather for 15-30 seconds. Rinse thoroughly with water. Dry hands completely.
Se mouiller les maines. Appliquer une quantité adéquate de savon et frotter les mains pendant 15 á 30 secondes jusqu á obtenir une mousse abondante. Rincer abondamment á l'eau. Sécher soigneusement.
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Warnings/Mises en Garde
This product is intended for external use only. Contact with the eyes should be avoided and should this occur, the eye should be flushed with water. If irritation develops or increases, use of the product should be disontinued. If irritattion persists for moe than 5 days, consult a physician. Keep out of reach of children.
Pour usage externe seulement, éviter tout contact avec les yeux, le cas échéant, rincer abondamment avec de l'eau, si une irritation apparaít ou s'accentue, cesser l'empoli. Si l'irritation persiste pendant plus de 5 jours, consulter un médcin. Garder hors de portée des enfants.
- Keep out of reach of children
- Inactive Ingredients
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PRINCIPAL DISPLAY PANEL
NDC 21749-461-89
Chlorhexidine Gluconate 2% Solution
Antiseptic Lotion Soap
Distributed by:
GOJO Industries, Inc.
Akron, OH 44309
330-255-6000
www.GOJO.com
GOJO Canada, Inc.
1100 Squires Beach Road
Pickering, ON L1W 3N8
FRONTTTFXCANLBLB
NDC 21749-461-89
Chlorhexidine Gluconate 2% Solution
Antiseptic Lotion Soap
Distributed by:
GOJO Industries, Inc.
Akron, OH 44309
330-255-6000
www.GOJO.com
GOJO Canada, Inc.
1100 Squires Beach Road
Pickering, ON L1W 3N8
BACKGOJOCANLBLA
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INGREDIENTS AND APPEARANCE
ANTISEPTIC FOAM HANDWASH
chlorhexidine gluconate 2% solution liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-461 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) COCO DIETHANOLAMIDE (UNII: 92005F972D) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21749-461-89 1200 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 12/01/2011 Labeler - GOJO Industries, Inc. (004162038) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc 007470579 manufacture(21749-461)