Label: HAND SANITIZER- ethyl alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 74128-070-04, 74128-070-08, 74128-080-01, 74128-080-16 - Packager: Tekkware, Inc. d.b.a. Gloucester Bio
- 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 12, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Alcohol (Ethyl Alcohol or Ethanol)
- Hand Sanitizer
- Inactive Ingredients
- Uses
- Keep out of reach of children
- Directions
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Warnings
For external use only. Flammable. Keep away from heat or flame.
- Do not use in children less than 2 months of age. Do not use on open skin wounds.
- When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
- Stop use and ask a doctor if irritation or rash occur. These may be signs of a serious condition.
- 473mL NDC: 74128-080-16
- 3785mL NDC: 74128-080-01
- 236mL NDC: 74128-070-08
- 118mL NDC: 74128-070-04
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74128-070 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) LEMON OIL (UNII: I9GRO824LL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74128-070-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:74128-070-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/30/2020 HAND SANITIZER
ethyl alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74128-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) LEMON OIL (UNII: I9GRO824LL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74128-080-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:74128-080-01 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/30/2020 Labeler - Tekkware, Inc. d.b.a. Gloucester Bio (085078398) Registrant - Tekkware, Inc. d.b.a. Gloucester Bio (085078398) Establishment Name Address ID/FEI Business Operations Tekkware, Inc, d.b.a. Gloucester Bio 085078398 manufacture(74128-070, 74128-080)
