Stay Away Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution

Stay Away Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution by

Drug Labeling and Warnings

Stay Away Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution by is a Otc medication manufactured, distributed, or labeled by Dvine Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STAY AWAY ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION- alcohol solution 
Dvine Laboratories 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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Stay Away Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution

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

59 mL NDC: 78747-001-01 Stay Away 59 ml label

118 mL NDC: 78747-001-02 Stay Away 118 ml label

473 mL NDC: 78747-001-03 Stay Away 473 ml label

946 mL NDC: 78747-001-04 Stay Away 946 ml label

3785 mL NDC: 78747-001-05 Stay Away 3785 ml label

STAY AWAY ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78747-001
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: 78747-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
2NDC: 78747-001-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
3NDC: 78747-001-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
4NDC: 78747-001-04946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
5NDC: 78747-001-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/29/202012/29/2020
Labeler - Dvine Laboratories Inc. (203454749)
Establishment
NameAddressID/FEIBusiness Operations
Dvine Laboratories Inc.203454749pack(78747-001) , manufacture(78747-001) , label(78747-001)

Revised: 12/2020
Document Id: b79fe100-6f58-7ea8-e053-2995a90a456f
Set id: a8ee83cf-ebb4-73b4-e053-2995a90a8ceb
Version: 3
Effective Time: 20201229