Label: EARTH EDITION HAND SANITIZER GEL- ethanol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76841-4806-1 - Packager: Earth Edition Inc.
- 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 10, 2020
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INGREDIENTS AND APPEARANCE
EARTH EDITION HAND SANITIZER GEL
ethanol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76841-4806 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 350 mL in 500 mL Inactive Ingredients Ingredient Name Strength GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) GLYCERIN (UNII: PDC6A3C0OX) ALLANTOIN (UNII: 344S277G0Z) ORANGE OIL (UNII: AKN3KSD11B) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) PANTHENOL (UNII: WV9CM0O67Z) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76841-4806-1 480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/10/2020 Labeler - Earth Edition Inc. (695625846) Establishment Name Address ID/FEI Business Operations Skin n Skin Co., Ltd. 631090037 manufacture(76841-4806)