b00b0c3e-2a45-4c53-9222-037abdfe85dc

SPL v1

SPL

SPL Set ID b00b0c3e-2a45-4c53-9222-037abdfe85dc

Route

topical

Published

Effective Date 2020-05-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

glycerin water trolamine

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-05-04

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v

Medication Information

Warnings

For external use only -hands

Flammable. Keep away from fire or flame

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 some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Water, glycerin, olive oil PEG-7 ester, acrylates /C10-30 alkyl acrylate cross polymer, triethanolamine, fragrance

Description

Ethyl Alcohol 75% v/v

Use

To reduce bacteria on the skin that could cause disease

Recommended for repeated use

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 develop and condistion persists for more than 72 hours

Section 50567-7

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

Avoid contact with broken skin

Do not inhale or ingest

Section 51945-4

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Structured Label Content

Warnings

For external use only -hands

Flammable. Keep away from fire or flame

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 some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients (Inactive ingredients)

Water, glycerin, olive oil PEG-7 ester, acrylates /C10-30 alkyl acrylate cross polymer, triethanolamine, fragrance

Use

To reduce bacteria on the skin that could cause disease

Recommended for repeated use

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 develop and condistion persists for more than 72 hours

Section 50567-7 (50567-7)

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

Avoid contact with broken skin

Do not inhale or ingest

Section 51945-4 (51945-4)

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "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 reduce bacteria on the skin that could cause disease Recommended for repeated use", "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 develop and condistion persists for more than 72 hours", "50567-7": "When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin Do not inhale or ingest", "Purpose": "Antiseptic", "Warnings": "For external use only -hands Flammable. Keep away from fire or flame", "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 some fabrics Harmful to wood finishes and plastics", "Active Ingredient(s)": "Ethyl Alcohol 75% v/v", "Inactive ingredients": "Water, glycerin, olive oil PEG-7 ester, acrylates /C10-30 alkyl acrylate cross polymer, triethanolamine, fragrance"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:26.382410 · Updated: 2026-03-14T22:56:37.078705