HAND SANITIZER- alcohol spray 
PrintJet Corp

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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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. 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.
  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)

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, Fragrance

Package Label - Principal Display Panel

3785 ml NDC: 76795-738-17

1 GAL SPRAY

946 ml NDC: 76795-738-16

946ML SPRAY

473 ml NDC: 76795-738-15

16 OZ SPRAY

237 ml NDC: 76795-738-14

8OZ SPRAY

177 ml NDC: 76795-738-13

6OZ SPRAY

118 ml NDC: 76795-737-12

118ML SPRAY

60 ml NDC: 76795-738-11

2OZ SPRAY

HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76795-738
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75.725 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 7.5 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.75 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 16 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.025 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76795-738-1160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/26/2020
2NDC:76795-738-12118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/26/2020
3NDC:76795-738-13177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/26/2020
4NDC:76795-738-14237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/26/2020
5NDC:76795-738-15473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/26/2020
6NDC:76795-738-16946 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/26/2020
7NDC:76795-738-173785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/26/2020
Labeler - PrintJet Corp (158605449)
Registrant - Sue L Sotelo (158605449)
Establishment
NameAddressID/FEIBusiness Operations
PrintJet Corp158605449manufacture(76795-738)

Revised: 4/2020
Document Id: a9ce77cd-4471-db1b-e053-2a95a90ade03
Set id: a9cef3f8-fd91-9ccc-e053-2995a90a0a35
Version: 1
Effective Time: 20200426
 
PrintJet Corp