Label: HAND SANITIZER gel
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Contains inactivated NDC Code(s)
NDC Code(s): 54823-005-01 - Packager: FUJIAN ISHINE COSMETICS 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 6, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
- Warnings
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- Directions:
- Other Information
- Inactive Ingredients:
- Package Label
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54823-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.01 mL in 100 mL CETEARETH-6 OLIVATE (UNII: 8834VWF9MO) 0.1 mL in 100 mL LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.01 mL in 100 mL METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) 0.01 mL in 100 mL HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) 0.01 mL in 100 mL ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) 0.01 mL in 100 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0001 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL in 100 mL BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.01 mL in 100 mL .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) 0.01 mL in 100 mL 1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y) 0.01 mL in 100 mL WATER (UNII: 059QF0KO0R) 23.9899 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL in 100 mL CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 0.3 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54823-005-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/09/2020 Labeler - FUJIAN ISHINE COSMETICS CO., LTD. (548232812) Registrant - FUJIAN ISHINE COSMETICS CO., LTD. (548232812) Establishment Name Address ID/FEI Business Operations FUJIAN ISHINE COSMETICS CO., LTD. 548232812 manufacture(54823-005)
