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SPL v9

SPL

SPL Set ID a5189240-19ce-7715-e053-2995a90ad043

Route

TOPICAL

Published

Effective Date 2020-04-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.125 mL)

Inactive Ingredients

Hydrogen Peroxide Water Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-04-30 Until 2049-12-31

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.

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Use

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

Section 42229-5

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 rash occurs. These may be signs of a serious condition.

Section 50567-7

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.

Warnings

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

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.

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)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

30 Ml Ndc: 77556 580 01

59 Ml Ndc: 77556 580 02

118 Ml Ndc: 77556 580 04

236 Ml Ndc: 77556 580 08

354 Ml Ndc: 77556 580 12

400 Ml Ndc: 77556 580 13

473 Ml Ndc: 77556 580 16

946 Ml Ndc: 77556 580 32

1000 Ml Ndc: 77556 580 33

2000 Ml Ndc: 77556 580 67

3785 Ml Ndc: 77556 580 93

18927 Ml Ndc: 77556 580 94

208198 Ml Ndc: 77556 580 95

1040990 Ml Ndc: 77556 580 97

1249190 Ml Ndc: 77556 580 99

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)

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 rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

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.

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)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, purified water USP

30 Ml Ndc: 77556 580 01 (30 ML NDC: 77556-580-01)

59 Ml Ndc: 77556 580 02 (59 ML NDC: 77556-580-02)

118 Ml Ndc: 77556 580 04 (118 ML NDC: 77556-580-04)

236 Ml Ndc: 77556 580 08 (236 ML NDC: 77556-580-08)

354 Ml Ndc: 77556 580 12 (354 ML NDC: 77556-580-12)

400 Ml Ndc: 77556 580 13 (400 ML NDC: 77556-580-13)

473 Ml Ndc: 77556 580 16 (473 ML NDC: 77556-580-16)

946 Ml Ndc: 77556 580 32 (946 ML NDC: 77556-580-32)

1000 Ml Ndc: 77556 580 33 (1000 ML NDC: 77556-580-33)

2000 Ml Ndc: 77556 580 67 (2000 ML NDC: 77556-580-67)

3785 Ml Ndc: 77556 580 93 (3785 ML NDC: 77556-580-93)

18927 Ml Ndc: 77556 580 94 (18927 ML NDC: 77556-580-94)

208198 Ml Ndc: 77556 580 95 (208198 ML NDC: 77556-580-95)

1040990 Ml Ndc: 77556 580 97 (1040990 ML NDC: 77556-580-97)

1249190 Ml Ndc: 77556 580 99 (1249190 ML NDC: 77556-580-99)

Advanced Ingredient Data

[{"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "0.125", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1.45", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are 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 right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "50567-7": "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.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "For external use only. Flammable. Keep away from heat or flame", "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.", "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)": "Alcohol 80% v/v. Purpose: Antiseptic", "Inactive ingredients": "glycerin, hydrogen peroxide, purified water USP"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:08.245107 · Updated: 2026-03-14T23:12:17.704012