EARTH EDITION HAND SANITIZER: Package Insert and Label Information

EARTH EDITION HAND SANITIZER- alcohol liquid
Earth Edition Inc.

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.

EARTH EDITION HAND SANITIZER
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EARTH EDITION HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76841-1108
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 88 mL in 110 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
HYDROGEN PEROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76841-1108-2 1 BOTTLE, SPRAY in 1 BOX contains a BOTTLE, SPRAY
1 110 mL in 1 BOTTLE, SPRAY This package is contained within the BOX (76841-1108-2)
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 Operations
Skin n Skin Co., Ltd. 631090037 manufacture (76841-1108)

Revised: 05/2020 Earth Edition Inc.

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