HAND SANITIZER- ethanol liquid 
HAND SANITIZER- isopropyl alcohol liquid 
M-I L.L.C.

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.

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Hand Santizer

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:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel 354 ml NDC: 75347-080-03

Package Label - Principal Display Panel 354 ml NDC: 75347-080-03Package Label - Principal Display Panel 1892 ml NDC: 75347-080-02Package Label - Principal Display Panel 18900 ml NDC: 75347-080-01Package Label - Principal Display Panel 236 ml NDC: 75347-080-04Package Label - Principal Display Panel 236 ml NDC: 75347-075-041892 ml_label Hand Sanitizer_75347-075-025 gal_Hand Sanitizer_75347-075-01354 ml NDC: 75347-075-03

HAND SANITIZER 
ethanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75347-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75347-080-0118900 mL in 1 PAIL; Type 0: Not a Combination Product04/30/2020
2NDC:75347-080-021892 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
3NDC:75347-080-03354 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
4NDC:75347-080-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/30/202012/31/2020
HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75347-075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75347-075-0118930 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
2NDC:75347-075-051892 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:75347-075-03354 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:75347-075-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - M-I L.L.C. (160801585)
Registrant - M-I L.L.C. (160801585)
Establishment
NameAddressID/FEIBusiness Operations
M-I L.L.C.160801585manufacture(75347-075, 75347-080)

Revised: 12/2020
Document Id: b71f1d63-b354-b056-e053-2a95a90a7792
Set id: a2f36b5f-57ff-34f4-e053-2a95a90a3836
Version: 4
Effective Time: 20201223
 
M-I L.L.C.