a43704c2-a9f8-b4e2-e053-2995a90af1c1

SPL v1

SPL

SPL Set ID a43704c2-a9f8-b4e2-e053-2995a90af1c1

Route

topical

Published

Effective Date 2020-04-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

carbomer 934 triethanolamine sulfate

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-26

Purpose

Antiseptic

Description

Medication Information

Warnings

For external use only.

Flammable. Keep away from heat and flame

Do not use in eyes, if this happens, rinse thoroughly with water

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry without wiping

Inactive Ingredients

Water, Carbomer, Triethanolamine

Description

Use

For hand washing to decrease bacteria on the skin without soap and water

Section 42229-5

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if irritation develops and persists for more than 72 hours. If ingested, get medical help or contact a poison control center right away

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only.

Flammable. Keep away from heat and flame

Do not use in eyes, if this happens, rinse thoroughly with water

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry without wiping

Inactive Ingredients (Inactive ingredients)

Water, Carbomer, Triethanolamine

Use

For hand washing to decrease bacteria on the skin without soap and water

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation develops and persists for more than 72 hours. If ingested, get medical help or contact a poison control center right away

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

Advanced Ingredient Data

[{"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE SULFATE", "unii": "MV1V89M17O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand washing to decrease bacteria on the skin without soap and water", "42229-5": "NA", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if irritation develops and persists for more than 72 hours. If ingested, get medical help or contact a poison control center right away", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat and flame Do not use in eyes, if this happens, rinse thoroughly with water", "Directions": "Wet hands thoroughly with product and allow to dry without wiping", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water, Carbomer, Triethanolamine"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:20.878416 · Updated: 2026-03-14T22:56:25.475172