Label: BIOMEDIK PREMIUM HAND SANITIZER GEL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74514-3785-1 - Packager: SISKINKOREA 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 May 31, 2020
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INGREDIENTS AND APPEARANCE
BIOMEDIK PREMIUM HAND SANITIZER GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74514-3785 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 2649.5 mL in 3785 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74514-3785-1 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/31/2020 Labeler - SISKINKOREA CO.,LTD. (695625974) Establishment Name Address ID/FEI Business Operations SISKINKOREA CO.,LTD. 695625974 manufacture(74514-3785)
