4af5db13-2cce-4cee-b737-d14491f5c435

SPL v3

SPL

SPL Set ID 4af5db13-2cce-4cee-b737-d14491f5c435

Route

topical

Published

Effective Date 2020-04-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

glycerin carbomer 934 triethanolamine sulfate peg-7 glyceryl cocoate

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-14

Purpose

Antiseptic

Description

Medication Information

Warnings

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

Discontinue if skin becomes irritated and ask a doctor

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and rub until dry without wiping
For children under 6, use only under adult supervision
Not recommended for infants

Other Information

Do not store above 105F
May discolor wood or fabrics
Harmful to wood finishes or plastics

Inactive Ingredients

Carbomer, Triethanolamine, Glycerin, PEG-7 glyceryl CoCoate, Water

Description

Use

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

To use anywhere without water

Section 42229-5

Section 50565-1

Keep out of reach of children. In case of accidental ingest, seek professional assist or contact a Poison Control Center immediately.

Section 50567-7

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Do not inhale or ingest

Avoid contact with broken skin

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

Discontinue if skin becomes irritated and ask a doctor

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and rub until dry without wiping
For children under 6, use only under adult supervision
Not recommended for infants

Other Information (Other information)

Do not store above 105F
May discolor wood or fabrics
Harmful to wood finishes or plastics

Inactive Ingredients (Inactive ingredients)

Carbomer, Triethanolamine, Glycerin, PEG-7 glyceryl CoCoate, Water

Use

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

To use anywhere without water

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingest, seek professional assist or contact a Poison Control Center immediately.

Section 50567-7 (50567-7)

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Do not inhale or ingest

Avoid contact with broken skin

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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": "PEG-7 GLYCERYL COCOATE", "unii": "VNX7251543", "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": "To decrease bacteria on the skin that could cause disease Recommended for repeated use To use anywhere without water", "42229-5": "NA", "50565-1": "Keep out of reach of children. In case of accidental ingest, seek professional assist or contact a Poison Control Center immediately.", "50567-7": "When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Do not inhale or ingest Avoid contact with broken skin", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat and flame Discontinue if skin becomes irritated and ask a doctor", "Directions": "Wet hands thoroughly with product and rub until dry without wiping For children under 6, use only under adult supervision Not recommended for infants", "Other information": "Do not store above 105F May discolor wood or fabrics Harmful to wood finishes or plastics", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Carbomer, Triethanolamine, Glycerin, PEG-7 glyceryl CoCoate, Water"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:49.033424 · Updated: 2026-03-14T22:57:06.397974