HAND SANITIZER- alcohol liquid 
SanitizeNow 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.

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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.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Ethyl Alcohol 80% (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Sterile distilled water or boiled cold water.
Hydrogen Peroxide
Glycerin

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)

Alcohol 80% 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

Water, Hydrogen Peroxide, Glycerin

Package Label - Principal Display Panel

18.95 L NDC: 74988-720-95 5 gal

29 mL NDC: 74988-720-10 29 ml59 mL NDC: 74988-720-20 59 ml118 mL NDC: 74988-720-40 118 ml236 mL NDC: 74988-720-80 236 ml 1236 mL NDC: 74988-720-81 236 ml 2 236 mL NDC: 74988-720-82 236 ml 3473 mL NDC: 74988-720-16 473 ml650 mL NDC: 74988-720-22 650 ml1 L NDC: 74988-720-11 1 Liter

3.79 L NDC: 74988-720-37 3.79 L208 L NDC: 74988-720-55 208 L

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74988-720
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
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:74988-720-1029 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
2NDC:74988-720-2059 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
3NDC:74988-720-40118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
4NDC:74988-720-80236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
5NDC:74988-720-81236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
6NDC:74988-720-82236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2020
7NDC:74988-720-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
8NDC:74988-720-22650 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
9NDC:74988-720-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
10NDC:74988-720-373790 mL in 1 JUG; Type 0: Not a Combination Product04/01/2020
11NDC:74988-720-55208000 mL in 1 DRUM; Type 0: Not a Combination Product04/01/2020
12NDC:74988-720-9518950 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product11/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2020
Labeler - SanitizeNow Inc. (117475870)
Establishment
NameAddressID/FEIBusiness Operations
SanitizeNow Inc.117475870manufacture(74988-720)

Revised: 11/2020
Document Id: b338d33c-f01d-e125-e053-2995a90a1a62
Set id: a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
Version: 2
Effective Time: 20201103
 
SanitizeNow Inc.