3207e6e8-807a-430b-b80c-d4354089db91

SPL v3

SPL

SPL Set ID 3207e6e8-807a-430b-b80c-d4354089db91

Route

topical

Published

Effective Date 2020-04-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

glycerol formal carbomer 934 triethanolamine sulfate

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-14

Purpose

Antiseptic

Description

Medication Information

Warnings

Flammable. Keep away from fire and flame. For external use only.

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry without wiping

Other Information

Store below 105F

Inactive Ingredients

Water, carbomer, triethanolamine, glycerol

Description

Use

For hand washing to decrease bacterial on the skin, only when water is not available

Section 42229-5

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 and redness develops

Section 50567-7

When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water. May discolor some fabrics

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

Structured Label Content

Warnings

Flammable. Keep away from fire and flame. For external use only.

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry without wiping

Other Information (Other information)

Store below 105F

Inactive Ingredients (Inactive ingredients)

Water, carbomer, triethanolamine, glycerol

Use

For hand washing to decrease bacterial on the skin, only when water is not available

Section 42229-5 (42229-5)

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 and redness develops

Section 50567-7 (50567-7)

When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water. May discolor some fabrics

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

Advanced Ingredient Data

[{"name": "GLYCEROL FORMAL", "unii": "3L7GR2604E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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 bacterial on the skin, only when water is not available", "42229-5": "NA", "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 and redness develops", "50567-7": "When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water. May discolor some fabrics", "Purpose": "Antiseptic", "Warnings": "Flammable. Keep away from fire and flame. For external use only.", "Directions": "Wet hands thoroughly with product and allow to dry without wiping", "Other information": "Store below 105F", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water, carbomer, triethanolamine, glycerol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:52.666458 · Updated: 2026-03-14T22:58:41.209834