Label: EWLEKA DISINFECTION GEL- 95%ethanol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79239-001-02 - Packager: Keqin Cosmetics(shanghai)Co.,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 July 2, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Alcohol
- Dosage
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Warnrings
1.This product is for external use, strictly forbidden to be taken orally.Please keep it out of reach of children.
2.This product contains alcohol, do not contact open flames.
3. This product contains alcohol, it should not be used if you are allergic to alhol.
4.This product is not suitable for disinfecting the surface of fat-soluble objects.
- Inactive ingredient
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Usage
Take 3ml of this product and apply it to your hands, rub your hands for one minute until it is dry.
Medical Surgery hand disinfection: Wash your hands, lower 1/3of upperarm as specified, than take5ml-10ml of this product and evenly apply it to yourhands , rub your hands for 3 minutes until it is dry, put onsterile gloves at last.
- Keep out of reach of children
- Purpose
- Active ingredient
- The labeling of Disinfection Gel
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INGREDIENTS AND APPEARANCE
EWLEKA DISINFECTION GEL
95%ethanol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79239-001 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) 5 mL in 100 mL WATER (UNII: 059QF0KO0R) 25 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79239-001-02 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/07/2020 Labeler - Keqin Cosmetics(shanghai)Co.,Ltd (554537587)