OTC Medication Information: Stay Away Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution

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.

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
(click image for full-size original)

118 mL NDC: 78747-001-02

Stay Away 118 ml label
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473 mL NDC: 78747-001-03

Stay Away 473 ml label
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946 mL NDC: 78747-001-04

Stay Away 946 ml label
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3785 mL NDC: 78747-001-05

Stay Away 3785 ml label
(click image for full-size original)

STAY AWAY ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION
alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78747-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 1.45 mL in 100 mL
HYDROGEN PEROXIDE 0.125 mL in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78747-001-01 59 mL in 1 BOTTLE None
2 NDC:78747-001-02 118 mL in 1 BOTTLE None
3 NDC:78747-001-03 473 mL in 1 BOTTLE None
4 NDC:78747-001-04 946 mL in 1 BOTTLE None
5 NDC:78747-001-05 3785 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/29/2020
Labeler — Dvine Laboratories Inc. (203454749)
Establishment
Name Address ID/FEI Operations
Dvine Laboratories Inc. 203454749 manufacture (78747-001)

Revised: 06/2020 Dvine Laboratories Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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