NEUTREVO LIQUID HAND DISINFECTANT- alcohol liquid

Neutrevo Liquid Hand Disinfectant by

Drug Labeling and Warnings

Neutrevo Liquid Hand Disinfectant by is a Otc medication manufactured, distributed, or labeled by SCK ZETA DIS TICARET PAZARLAMA LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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) (70%, 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
3. Hydrogen peroxide
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 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Liquid hand disinfectant to help reduce bacteria on the skin.

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

Avoid direct contact with eyes. Highly flammable liquid and vapour.

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Keep container tightly closed. Use only non-sparking tools. Store in a well ventilated place. Keep cool.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply a small amount of the liquid on the palm of your hand and rub your hands until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 86 F (30 C).

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

100 mL NDC: 86818-003-01

250 ml NDC: 86818-003-02

500 ml NDC: 86818-003-03

1000 ml NDC: 86818-003-04

INGREDIENTS AND APPEARANCE

NEUTREVO LIQUID HAND DISINFECTANT 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86818-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86818-003-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 86818-003-02	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
3	NDC: 86818-003-03	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
4	NDC: 86818-003-04	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - SCK ZETA DIS TICARET PAZARLAMA LIMITED SIRKETI (356290986)

Registrant - SCK ZETA DIS TICARET PAZARLAMA LIMITED SIRKETI (356290986)

Establishment
Name	Address	ID/FEI	Business Operations
SCK ZETA DIS TICARET PAZARLAMA LIMITED SIRKETI		356290986	manufacture(86818-003)