Label: 3E CLEAN HAND SANITIZER- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78896-001-01 - Packager: Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI.
- 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 June 19, 2020
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INGREDIENTS AND APPEARANCE
3E CLEAN HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78896-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) DMDM HYDANTOIN (UNII: BYR0546TOW) TROLAMINE (UNII: 9O3K93S3TK) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) COUMARIN (UNII: A4VZ22K1WT) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BENZYL ALCOHOL (UNII: LKG8494WBH) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78896-001-01 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/20/2020 Labeler - Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI. (533147719) Establishment Name Address ID/FEI Business Operations Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI. 533147719 manufacture(78896-001) , label(78896-001) , pack(78896-001) , relabel(78896-001) , repack(78896-001) , transfill(78896-001)