Label: ETHYL ALCOHOL gel
- NDC Code(s): 49035-694-10, 49035-694-16
- Packager: Wal-Mart Stores, Inc.
- 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 December 6, 2022
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- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Principal display panel
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INGREDIENTS AND APPEARANCE
ETHYL ALCOHOL
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-694 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 620 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-694-10 29.5 mL in 1 PACKAGE; Type 0: Not a Combination Product 01/03/2020 2 NDC:49035-694-16 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/03/2020 Labeler - Wal-Mart Stores, Inc. (051957769) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(49035-694) Establishment Name Address ID/FEI Business Operations Nantong Health & Beyond Hygenic Products, Inc. 421280161 manufacture(49035-694)