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Hand Sanitizer Spritz

Medically reviewed by Drugs.com. Last updated on Jul 21, 2020.

Dosage form: liquid
Ingredients: ALCOHOL 80mL in 100mL
Labeler: New Directions Aromatics Inc.
NDC Code: 74179-900

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 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
  • in children less than 2 months of age
  • on open skin wounds

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
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

473 mL NDC: 74179-900-01

200 L NDC: 74179-900-02

60 mL NDC: 74179-900-03

1000 mL NDC: 74179-900-04

240 mL NDC: 74179-900-05

HAND SANITIZER SPRITZ 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74179-900
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN1.45 mL  in 100 mL
HYDROGEN PEROXIDE0.125 mL  in 100 mL
WATER 
Packaging
#Item CodePackage Description
1NDC:74179-900-01473 mL in 1 BOTTLE, SPRAY
2NDC:74179-900-02200000 mL in 1 DRUM
3NDC:74179-900-0360 mL in 1 BOTTLE, SPRAY
4NDC:74179-900-041000000 mL in 1 TANK
5NDC:74179-900-05240 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - New Directions Aromatics Inc. (200570278)
Registrant - New Directions Aromatics Inc. (200570278)
Establishment
NameAddressID/FEIOperations
New Directions Aromatics Inc.200570278manufacture(74179-900)

 
New Directions Aromatics Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.