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SPL v1

SPL

SPL Set ID 0f3c0909-00ad-4b91-9dcd-a90af4a9b65f

Route

TOPICAL

Published

Effective Date 2020-05-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-16

Description

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Use

Hand Sanitizer to decrease bacteria on the skin that could cause disease

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 consult a doctor if irritation or redness occurs.

Section 50567-7

When using this product, avoid contacting with face, eyes, and broken skin. In case of eye contacting, flush with plenty of water and seek medical advice.

Section 51945-4

Warnings

For external use only. Hands

Flammable. Keep away from heat and flame

Directions

Rub hands thoroughly with this product until dry

Children younger than 6 should be supervised by an adult when using

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

This product was not tested on animals

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients

Water

Structured Label Content

Use

Hand Sanitizer to decrease bacteria on the skin that could cause disease

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 consult a doctor if irritation or redness occurs.

Section 50567-7 (50567-7)

When using this product, avoid contacting with face, eyes, and broken skin. In case of eye contacting, flush with plenty of water and seek medical advice.

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For external use only. Hands

Flammable. Keep away from heat and flame

Directions

Rub hands thoroughly with this product until dry

Children younger than 6 should be supervised by an adult when using

Other Information (Other information)

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

This product was not tested on animals

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "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": "Hand Sanitizer to decrease bacteria on the skin that could cause disease", "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 consult a doctor if irritation or redness occurs.", "50567-7": "When using this product, avoid contacting with face, eyes, and broken skin. In case of eye contacting, flush with plenty of water and seek medical advice.", "Purpose": "Antimicrobial", "Warnings": "For external use only. Hands Flammable. Keep away from heat and flame", "Directions": "Rub hands thoroughly with this product until dry Children younger than 6 should be supervised by an adult when using", "Other information": "Do not store above 105F May discolor some fabrics Harmful to wood finishes and plastics This product was not tested on animals", "Active Ingredient(s)": "Ethyl Alcohol 75% v/v", "Inactive ingredients": "Water"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:36.142663 · Updated: 2026-03-14T22:56:49.307601