Label: E D HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78885-001-00 - Packager: ENSOBRETADOS Y DERIVADOS S.A. DE C.V. E&D
- 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 15, 2020
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- USES
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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
■ 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 occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- E&D HAND SANITIZER 1 mL (NDC 78885-001-00)
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INGREDIENTS AND APPEARANCE
E D HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78885-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78885-001-00 1 mL in 1 PACKET; Type 0: Not a Combination Product 06/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/15/2020 Labeler - ENSOBRETADOS Y DERIVADOS S.A. DE C.V. E&D (813382660) Registrant - ENSOBRETADOS Y DERIVADOS S.A. DE C.V. E&D (813382660) Establishment Name Address ID/FEI Business Operations ENSOBRETADOS Y DERIVADOS S.A. DE C.V. E&D 813382660 manufacture(78885-001)