75556-591 59.1 Ml Shunan

Drug Facts

Composition & Product

Active Ingredients

Alcohol (44.325 mL)

Inactive Ingredients

Carbomer Homopolymer, Unspecified Type Glycerin Water Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-20

Medication Information

Purpose

Antiseptic, 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) (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 decrease bacteria on the skin, only when water is 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) (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 immediately.

Section 50566-9

Stop use and ask a doctor if

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

Section 50567-7

When using this product . Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. May discolor some fabrics.

Warnings

Flammable. Keep away from fire and flame.
For external use only.

Directions

wet hands thoroughly with product and allow to dry without wiping.

Do Not Use

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

Other Information

Store below 105℉

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

Water,Carbomer, Triethanolamine, Glycerol

Package Label Principal Display Panel

59.1 mL in 1 Bottle NDC: 75556-591-01

Structured Label Content

Use

to decrease bacteria on the skin, only when water is 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) (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 immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

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

Section 50567-7 (50567-7)

When using this product . Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. May discolor some fabrics.

Purpose

Antiseptic, Hand Sanitizer

Warnings

Flammable. Keep away from fire and flame.
For external use only.

Directions

wet hands thoroughly with product and allow to dry without wiping.

Do Not Use (Do not use)

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

Other Information (Other information)

Store below 105℉

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water,Carbomer, Triethanolamine, Glycerol

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

59.1 mL in 1 Bottle NDC: 75556-591-01

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "44.325", "strengthDenominator": "59.1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "to decrease bacteria on the skin, only when water is not available.", "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 immediately.", "50566-9": "Stop use and ask a doctor if Irritation or redness develop Keep out of reach of children If swallowed. get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product . Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. May discolor some fabrics.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "Flammable. Keep away from fire and flame. For external use only.", "Directions": "wet hands thoroughly with product and allow to dry without wiping.", "Do not use": "in children less than 2 months of age on open skin wounds", "Other information": "Store below 105℉", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water,Carbomer, Triethanolamine, Glycerol", "Package Label - Principal Display Panel": "59.1 mL in 1 Bottle NDC: 75556-591-01"}