Biogenix Hand Sanitizer Gel

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.5 mL)

Inactive Ingredients

Carbomer 940 Etidronate Tetrasodium Glycerin Trolamine Water Lavender Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Medication Information

Purpose

Antimicrobial, Hand Sanitizer

Description

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: 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. Glycerol (1.2% v/v). Triethanolamin (0.2% v/v). EDTA (0.2% v/v). Carbomer (0.5% v/v). Lavander Oil (0.7% v/v). water The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5

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:

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.
Glycerol (1.2% v/v).
Triethanolamin (0.2% v/v).
EDTA (0.2% v/v).
Carbomer (0.5% v/v).
Lavander Oil (0.7% v/v).
water

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product do not use in or near the eyes. 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.

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Do Not Use

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

Other Information

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

Active Ingredient(s)

Ethyl Alcohol 70% (v/v), Antimicrobial

Inactive Ingredients

Carbomer, EDTA, Glycerin, Lavander Oil, Triethanolamine, purified water

Package Label Principal Display Panel

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5 (42229-5)

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:

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.
Glycerol (1.2% v/v).
Triethanolamin (0.2% v/v).
EDTA (0.2% v/v).
Carbomer (0.5% v/v).
Lavander Oil (0.7% v/v).
water

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. 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.

Purpose

Antimicrobial, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Do Not Use (Do not use)

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

Other Information (Other information)

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

Active Ingredient(s)

Ethyl Alcohol 70% (v/v), Antimicrobial

Inactive Ingredients (Inactive ingredients)

Carbomer, EDTA, Glycerin, Lavander Oil, Triethanolamine, purified water

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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