SPL v1
SPL
SPL Set ID a4de7ce7-4a92-7c12-e053-2995a90a195e
Route
TOPICAL
Published
Effective Date 2020-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (29.4 mL)
Inactive Ingredients
Water Polyacrylic Acid (8000 Mw) Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-06
Description

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.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

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.

Use(s)

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Section 51945-4

3.78 L

NDC: 77268-001-01

Warnings

Flammable, keep away from fire and flames

For external use only.

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

Active Ingredient(s)

Ethyl alcohol 70% v/v

Inactive Ingredients

water, polyacrylic acid, and triethanolamine.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use(s)

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Section 51945-4 (51945-4)

3.78 L

NDC: 77268-001-01

Purpose

Antiseptic

Warnings

Flammable, keep away from fire and flames

For external use only.

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

Active Ingredient(s)

Ethyl alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

water, polyacrylic acid, and triethanolamine.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:27.079997 · Updated: 2026-03-14T22:56:37.078705