Label: HAND SANITIZER- alcohol gel
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NDC Code(s):
77478-455-01,
77478-455-05,
77478-455-10,
77478-455-11, view more77478-455-12, 77478-455-25, 77478-455-37, 77478-455-50
- Packager: TJP Labs Inc
- Category: HUMAN OTC DRUG LABEL
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 January 10, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77478-455 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) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77478-455-12 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:77478-455-50 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 3 NDC:77478-455-10 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 4 NDC:77478-455-25 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 5 NDC:77478-455-01 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 6 NDC:77478-455-05 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 7 NDC:77478-455-37 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 8 NDC:77478-455-11 1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product 09/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - TJP Labs Inc (200687904) Establishment Name Address ID/FEI Business Operations TJP Labs Inc 200687904 manufacture(77478-455)