DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Alcohol (1 mL)

Inactive Ingredients

Butylene Glycol Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-08-01

Medication Information

Purpose

Antiseptic

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) (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. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). 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.

Use

to help reduce bacteria on skin

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) (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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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.

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 redness occurs.

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Do not inhale or ingest. Avoid contact with broken skin

Warnings

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

Directions

Spray on hands throughly and rub until dry

Other Information

Do not store above 110F (43C)
May discolor certain fabrics and surfaces

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

Aqua (Water), Glycerin, Butylene Glycol, Fragrance (Parfum), , Aloe Barbadensis Leaf Extract, Artemisia Argyi Leaf Extract, Cnidium Monnieri Fruit Extract, Sargassum Fusiforme Extract

Package Label Principal Display Panel

56 mL NDC: 81282-048-01

Structured Label Content

Use

to help reduce bacteria on skin

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) (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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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.

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 redness occurs.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Do not inhale or ingest. Avoid contact with broken skin

Purpose

Antiseptic

Warnings

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

Directions

Spray on hands throughly and rub until dry

Other Information (Other information)

Do not store above 110F (43C)
May discolor certain fabrics and surfaces

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Glycerin, Butylene Glycol, Fragrance (Parfum), , Aloe Barbadensis Leaf Extract, Artemisia Argyi Leaf Extract, Cnidium Monnieri Fruit Extract, Sargassum Fusiforme Extract

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

56 mL NDC: 81282-048-01

Advanced Ingredient Data

[{"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "23", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "to help reduce bacteria on skin", "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) (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. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). 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.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or redness occurs.", "50567-7": "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale or ingest. Avoid contact with broken skin", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from fire, flame or high heat", "Directions": "Spray on hands throughly and rub until dry", "Other information": "Do not store above 110F (43C) May discolor certain fabrics and surfaces", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Aqua (Water), Glycerin, Butylene Glycol, Fragrance (Parfum), , Aloe Barbadensis Leaf Extract, Artemisia Argyi Leaf Extract, Cnidium Monnieri Fruit Extract, Sargassum Fusiforme Extract", "Package Label - Principal Display Panel": "56 mL NDC: 81282-048-01"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information