Label: ECO SANITIZER GEL- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80731-002-01, 80731-002-03, 80731-002-04, 80731-002-05 - Packager: 0966452 B.C. Ltd.
- 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 October 28, 2020
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- Official Label (Printer Friendly)
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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WARNINGS
Warning: For external use only. Keep out of reach of children. Flammable. Keep away from open flame and sources of heat. Avoid contact with eyes. Should this occur, flush eyes with water. If irritation develops, discontinue use and contact a health care practitioner. Store between 15°C/59°F and 30°C/86°F.
Contraindications: Do not use on children/infants less than 2 years of age (unless directed by a health care practitioner).
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ECO SANITIZER GEL
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80731-002 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) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80731-002-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2020 2 NDC:80731-002-05 320 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/27/2020 3 NDC:80731-002-03 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2020 4 NDC:80731-002-04 4000 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/08/2020 Labeler - 0966452 B.C. Ltd. (204193445) Establishment Name Address ID/FEI Business Operations 0966452 B.C. Ltd. 204193445 manufacture(80731-002)
