Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74341-194-15, 74341-194-53, 74341-194-60, 74341-194-73 - Packager: Newacme llc
- 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 January 21, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
- Package Labeling: 15 ml
- Package Labeling: 53 ml
- Package Labeling: 60 ml
- Package Labeling: 473 ml
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74341-194 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74341-194-15 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2020 2 NDC:74341-194-53 53 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2020 12/31/2021 3 NDC:74341-194-60 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2020 4 NDC:74341-194-73 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2020 12/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/20/2020 Labeler - Newacme llc (117465743) Establishment Name Address ID/FEI Business Operations Zhejiang Ayan Biotech Co.,Ltd. 544377996 manufacture(74341-194)