Label: ANTI-BACTER HAND SANITIZER 70 ETHYL ALCOHOL MELON- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80457-005-01 - Packager: ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI
- 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 March 8, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses
- Warnings:
- Directions
- Other information
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Inactive Ingredients:
AQUA (WATER), GLYCERIN, ALOE BARBADENSIS LEAF JUICE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER / CARBOMER*, MANNITOL, MICROCRYSTALLINE CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ALOE BARBADENSIS LEAF JUICE POWDER, TOCOPHERYL ACETATE, ALGIN, PARFUM (FRAGRANCE), AMINOMETHYL PROPANOL, BENZOPHENONE-3, POTASSIUM SORBATE, SODIUM BENZOATE, CI 74260, CI 77492 (IRON OXIDES), CI 19140 (FD&C YELLOW 5), CI 42090 (BLUE 1).
*The letter next to the batch number means:
A-ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER B-CARBOMER - Package Labeling:
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INGREDIENTS AND APPEARANCE
ANTI-BACTER HAND SANITIZER 70 ETHYL ALCOHOL MELON
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80457-005 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) ALOE VERA LEAF (UNII: ZY81Z83H0X) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ALGINATE (UNII: C269C4G2ZQ) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) OXYBENZONE (UNII: 95OOS7VE0Y) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80457-005-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2021 Labeler - ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI (366050458)