SPL v3
SPL
SPL Set ID a8ffb2dd-e8a3-de7a-e053-2995a90a33b3
Route
TOPICAL
Published
Effective Date 2020-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (1.45 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-26
Description

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. The hand sanitizer is manufactured using only the following ingredients in the preparation of the product: Alcohol (ethanol) (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. Sterile distilled water or boiled cold water. Hydrogen Peroxide Glycerin 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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. The hand sanitizer is manufactured using only the following ingredients in the preparation of the product: Alcohol (ethanol) (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. Sterile distilled water or boiled cold water. Hydrogen Peroxide Glycerin 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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Alcohol (ethanol) (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.

Sterile distilled water or boiled cold water.

Hydrogen Peroxide

Glycerin

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

Water, Hydrogen Peroxide, Glycerin.

Package Label Principal Display Panel

59 mL NDC: 74988-737-20



118 mL NDC: 74988-737-40


236 mL NDC: 74988-737-80


473 mL NDC: 74988-737-16


3.78 L NDC: 74988-737-37

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)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Alcohol (ethanol) (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.

Sterile distilled water or boiled cold water.

Hydrogen Peroxide

Glycerin

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 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 (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)

Water, Hydrogen Peroxide, Glycerin.

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

59 mL NDC: 74988-737-20



118 mL NDC: 74988-737-40


236 mL NDC: 74988-737-80


473 mL NDC: 74988-737-16


3.78 L NDC: 74988-737-37

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:15.333048 · Updated: 2026-03-14T22:59:10.507926