Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75778-005-11, 75778-005-23, 75778-005-47, 75778-005-60 - Packager: Audy Global Enterprises Inc.
- 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 June 19, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Inactive ingredients
- Directions
- Other information
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75778-005 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) POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75778-005-60 60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 06/19/2020 2 NDC:75778-005-11 118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 06/19/2020 3 NDC:75778-005-23 236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 06/19/2020 4 NDC:75778-005-47 473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 06/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/19/2020 Labeler - Audy Global Enterprises Inc. (079171473) Establishment Name Address ID/FEI Business Operations GRUPO DE ZAVALETA S.A. DE C.V. 951577304 manufacture(75778-005)