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SPL v1

SPL

SPL Set ID bcc173ac-8d47-28d2-e053-2a95a90a5e14

Route

TOPICAL

Published

Effective Date 2021-03-05

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 2021-03-05

Description

Ethyl alcohol

Medication Information

Warnings and Precautions

For external use only. Flammable.Keep away form fire or flame.

Description

Ethyl alcohol

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.

Section 50565-1

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs.

Section 50567-7

When using this product keep out of eyes,ears and mouth.

Section 51727-6

Purified water

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Ethyl alcohol

Directions

wet hands thoroughly with wipes, rub hands together until dry

Other Information

Store between 59-86°F(15-30°C)

Avoid freezing and excessive heat above 104°F(40°C)

Structured Label Content

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.

Warnings and Precautions (34071-1)

For external use only. Flammable.Keep away form fire or flame.

Section 50565-1 (50565-1)

Keep out of reach of children. lf 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 or rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes,ears and mouth.

Section 51727-6 (51727-6)

Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Ethyl alcohol

Directions

wet hands thoroughly with wipes, rub hands together until dry

Other Information (other information)

Store between 59-86°F(15-30°C)

Avoid freezing and excessive heat above 104°F(40°C)

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use[s]": "Hand sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.", "34071-1": "For external use only. Flammable.Keep away form fire or flame.", "50565-1": "Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs.", "50567-7": "When using this product keep out of eyes,ears and mouth.", "51727-6": "Purified water", "55105-1": "Antiseptic", "55106-9": "Ethyl alcohol", "Directions": "wet hands thoroughly with wipes, rub hands together until dry", "other information": "Store between 59-86°F(15-30°C) Avoid freezing and excessive heat above 104°F(40°C)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:26.444039 · Updated: 2026-03-14T22:59:25.623456