a4de7ce7-4a92-7c12-e053-2995a90a195e

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

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.

Medication Information

Warnings

Flammable, keep away from fire and flames

For external use only.

Purpose

Antiseptic

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.

Inactive Ingredients

water, polyacrylic acid, and triethanolamine.

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

Do Not Use

In children less than 2 months of age

On open skin wounds

Active Ingredient(s)

Ethyl alcohol 70% v/v

Keep Out of Reach of Children

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

Structured Label Content

Warnings

Flammable, keep away from fire and flames

For external use only.

Purpose

Antiseptic

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.

Inactive Ingredients (Inactive ingredients)

water, polyacrylic acid, and triethanolamine.

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

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

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

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "29.4", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "POLYACRYLIC ACID (8000 MW)", "unii": "73861X4K5F", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease.", "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": "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."}

Additional Information

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