Label: GEL HAND SANITIZER- moisturizing gel hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75396-315-17, 75396-315-18, 75396-315-19 - Packager: BuckAirways Inc.
- 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 5, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
- Packaging Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
GEL HAND SANITIZER
moisturizing gel hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75396-315 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 .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) DEXPANTHENOL (UNII: 1O6C93RI7Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75396-315-17 118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 05/25/2020 2 NDC:75396-315-18 59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 05/25/2020 3 NDC:75396-315-19 3785 mL in 1 JUG; Type 0: Not a Combination Product 05/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/18/2020 Labeler - BuckAirways Inc. (117488255) Registrant - Berdor Health (117488255) Establishment Name Address ID/FEI Business Operations BuckAirways Inc. 117488255 manufacture(75396-315)