Label: K.VI ZERO SANITIZER- ethanol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78394-030-01 - Packager: HWAJIN BIO COSMETICS 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 June 19, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
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WARNINGS
For external use only. Flammable. Keep away from heat or flame.
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Do not use
• In children less than 2 months of age
• On open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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
- Uses
- Directions
- Other information
- PACKAGE LABEL : K.vi-zero Sanitizer Gel
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INGREDIENTS AND APPEARANCE
K.VI ZERO SANITIZER
ethanol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78394-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 35 g in 50 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) MORUS ALBA ROOT (UNII: CST1G9BZGD) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78394-030-01 50 g in 1 TUBE; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/01/2020 Labeler - HWAJIN BIO COSMETICS CO., LTD. (688012988) Registrant - HWAJIN BIO COSMETICS CO., LTD. (688012988) Establishment Name Address ID/FEI Business Operations HWAJIN BIO COSMETICS CO., LTD. 688012988 manufacture(78394-030)