Label: VENCER HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78454-010-01, 78454-010-02, 78454-010-03 - Packager: GNST 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 2, 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 : VENCER Hand Sanitizer Gel 100mL
- Package Label : VENCER Hand Sanitizer Gel 500mL
- Package Label : VENCER Hand Sanitizer Gel 1000mL
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INGREDIENTS AND APPEARANCE
VENCER HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78454-010 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) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB) Butylene Glycol (UNII: 3XUS85K0RA) 1,2-Hexanediol (UNII: TR046Y3K1G) TROLAMINE (UNII: 9O3K93S3TK) LEMON OIL (UNII: I9GRO824LL) TEA TREE OIL (UNII: VIF565UC2G) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Panthenol (UNII: WV9CM0O67Z) PANTOLACTONE, (R)- (UNII: J288D7O0JS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78454-010-01 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2020 2 NDC:78454-010-02 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2020 3 NDC:78454-010-03 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 Labeler - GNST Co.,Ltd. (688254438) Registrant - GNST Co.,Ltd. (688254438) Establishment Name Address ID/FEI Business Operations GNST Co.,Ltd. 688254438 manufacture(78454-010)