Label: 80% WITH DENATURANT AND FRAGRANCE- easy ecosave liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 81184-005-03, 81184-005-05 - Packager: Easy Energy Systems, 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 July 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
- Denaturant
- Fragrance
- Active Ingredient(s)
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
80% WITH DENATURANT AND FRAGRANCE
easy ecosave liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81184-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 3028 mL in 3785 mL Inactive Ingredients Ingredient Name Strength COUMARIN (UNII: A4VZ22K1WT) 17.94 mL in 3785 mL GLYCEROL FORMAL (UNII: 3L7GR2604E) 54.9 mL in 3785 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 4.73 mL in 3785 mL WATER (UNII: 059QF0KO0R) 679 mL in 3785 mL DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 15.1 mg in 3785 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81184-005-05 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 2 NDC:81184-005-03 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/01/2021 Labeler - Easy Energy Systems, Inc. (789869885) Registrant - Easy Energy Systems, Inc. (789869885) Establishment Name Address ID/FEI Business Operations Easy Energy Systems, Inc. 789869885 manufacture(81184-005)
