Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50061-002-02, 50061-002-08, 50061-002-16, 50061-002-33 - Packager: FAZ Marketing
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated June 29, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient/Ingrediente Activo
- Purpose/Propósito
- Uses/Usos
- Warnings/Advertencias
- When using this product/Al utilizar este producto
- Stop use and ask a doctor if/Suspenda su uso y consulte a un médico
- Keep out of reach of children/Mantener fuera del alcance de los niños.
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Directions/Modo de uso
■Place enough product in your palm to thoroughly cover your hands. * Rub hands together briskly until dry. * Children under 6 years of age should be supervised when using this product/* Aplique suficiente cantidad del producto en la palma de la mano para cubrir completamente. * Frotar las manos vigorosamente hasta que se sequen. * El uso de este producto por niños menores de 6 años deberá ser supervisado.
- Inactive Ingredients/Ingredientes inactivos
- Other information/Otra Información
- Package Label
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50061-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50061-002-08 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2020 2 NDC:50061-002-02 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2020 3 NDC:50061-002-16 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2020 4 NDC:50061-002-33 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/22/2020 Labeler - FAZ Marketing (625680645)