Label: ALAN623 HAND CLEAN GEL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70987-562-01 - Packager: BEAUTIST 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 April 20, 2020
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INGREDIENTS AND APPEARANCE
ALAN623 HAND CLEAN GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70987-562 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 310 mL in 500 mL Inactive Ingredients Ingredient Name Strength LAVENDER OIL (UNII: ZBP1YXW0H8) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70987-562-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/01/2020 Labeler - BEAUTIST CO., LTD. (689847413) Establishment Name Address ID/FEI Business Operations BEAUTIST CO., LTD. 689847413 manufacture(70987-562)