HAND SANITIZER- alcohol gel 
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:

Alcohol (ethanol) (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
Isopropyl Myristate 0% to < 0.25%
Propylene Glycol
Carbomer and/or acrylates/alkyl polymers
Aloe Arborescens Leaf
Tocopheryl Acetate
Fragrance

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 70% 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, Carbomer and/or Crosspolymers, Isopropyl Myristate 0% to < 0.25%, Propylene Glycol, Aloe Arborescens Leaf and/or Tocopheryl Acetate, Fragrance.

Package Label - Principal Display Panel

355 mL NDC: 74988-731-35 12OZ

59 mL NDC: 74988-731-20 2 oz
118 mL NDC: 74988-731-40 4 oz
236 mL NDC: 74988-731-80 8 oz
473 mL NDC: 74988-731-16 16 oz
3.79 L NDC: 74988-731-37 1 gal
208 L NDC: 74988-731-55 55 gal
1041 L NDC: 74988-731-41 275 gal
25741 L NDC: 74988-731-74 tanker

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74988-731
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74988-731-2059 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
2NDC:74988-731-40118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
3NDC:74988-731-80236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
4NDC:74988-731-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
5NDC:74988-731-373790 mL in 1 JUG; Type 0: Not a Combination Product06/15/2020
6NDC:74988-731-55208000 mL in 1 DRUM; Type 0: Not a Combination Product06/15/2020
7NDC:74988-731-411041000 mL in 1 TANK; Type 0: Not a Combination Product06/15/2020
8NDC:74988-731-7425741000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/15/2020
9NDC:74988-731-35355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/2020
Labeler - SanitizeNow Inc. (117475870)
Establishment
NameAddressID/FEIBusiness Operations
SanitizeNow Inc.117475870manufacture(74988-731)

Revised: 10/2020
Document Id: b1d0f168-6e59-7f32-e053-2a95a90a7a36
Set id: a820cdea-2972-3f10-e053-2a95a90afa4b
Version: 4
Effective Time: 20201016
 
SanitizeNow Inc.