HAND SANITIZER- isopropyl 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:

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.
Sterile distilled water or boiled cold water.
Hydrogen Peroxide
Glycerin
Carbomer 1342
Aloe Vera Leaf
FD&C Blue No. 1
FD&C Yellow No. 5
Alpha Tocopherol 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)

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

Water, Hydrogen Peroxide, Glycerin, Carbomer 1342, Aloe Vera Leaf, FD&C Blue No. 1, FD&C Yellow No. 5, Alpha Tocopherol Acetate, Fragrance.

Package Label - Principal Display Panel

59 mL NDC: 74988-760-20 2 oz

118 mL NDC: 74988-760-40 4 oz

236 mL NDC: 74988-760-80 8 oz

473 mL NDC: 74988-760-16 16 oz

3.79 L NDC: 74988-760-37 1 gallon

208 L NDC: 74988-760-55 55 gal

1041 L NDC: 74988-760-41 tote

25741 L NDC: 74988-760-74 tanker

HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74988-760
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)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 1342 (UNII: 809Y72KV36)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74988-760-2059 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
2NDC:74988-760-80236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
3NDC:74988-760-40118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
4NDC:74988-760-373790 mL in 1 JUG; Type 0: Not a Combination Product05/20/2020
5NDC:74988-760-55208000 mL in 1 DRUM; Type 0: Not a Combination Product05/20/2020
6NDC:74988-760-411041000 mL in 1 TANK; Type 0: Not a Combination Product05/20/2020
7NDC:74988-760-7425741000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/20/2020
8NDC:74988-760-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2020
Labeler - SanitizeNow Inc. (117475870)
Establishment
NameAddressID/FEIBusiness Operations
SanitizeNow Inc.117475870manufacture(74988-760)

Revised: 6/2020
Document Id: a84dadc7-e989-4ba9-e053-2a95a90a89a5
Set id: a61ab277-457c-1517-e053-2995a90ae7a8
Version: 3
Effective Time: 20200617
 
SanitizeNow Inc.