Label: AFFEX CARE HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79097-023-01, 79097-023-02, 79097-023-03, 79097-023-04, view more79097-023-08, 79097-023-12, 79097-023-16, 79097-023-28, 79097-023-75 - Packager: Autotrol Corporation
- Category: HUMAN OTC DRUG LABEL
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 December 6, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- INSTRUCTIONS FOR USE
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
- WHEN USING
- STOP USE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AFFEX CARE HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79097-023 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 ALOE (UNII: V5VD430YW9) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79097-023-01 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2020 2 NDC:79097-023-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2020 3 NDC:79097-023-03 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2020 4 NDC:79097-023-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2020 5 NDC:79097-023-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2020 6 NDC:79097-023-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2020 7 NDC:79097-023-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2020 8 NDC:79097-023-28 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2020 9 NDC:79097-023-75 1000000 mL in 1 TANK; Type 0: Not a Combination Product 07/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/13/2020 Labeler - Autotrol Corporation (001755131) Establishment Name Address ID/FEI Business Operations Autotrol Corporation 001755131 label(79097-023) , manufacture(79097-023) , pack(79097-023)