Label: 5253 HAND SANITIZER- ethyl alcohol gel
- NDC Code(s): 76138-117-02
- Packager: Innovation Specialties
- This is a repackaged label.
- Source NDC Code(s): 70412-110
- 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 December 13, 2022
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- Drug Facts
- Active Ingredient
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- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
5253 HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76138-117(NDC:70412-110) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76138-117-02 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/16/2018 Labeler - Innovation Specialties (030837314) Establishment Name Address ID/FEI Business Operations Innovation Specialties 030837314 relabel(76138-117) , repack(76138-117)
