77975-015 Hand Sanitizer

SPL v2

SPL

SPL Set ID 0b6f5095-7677-e5ce-e063-6294a90a91c9

Route

CUTANEOUS

Published

Effective Date 2023-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Water Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Peg-40 Castor Oil Lemon Peel

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-06

Description

ETHYL ALCOHOL 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

ETHYL ALCOHOL 62%

Use

Uses To decrease bacteria andgerms on the skin Recommended for repeated use.

Section 50565-1

Keep out of reach of chlldren. If swallowed. get medical help or contact a Polson Control center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be sians of a serious condition.

Section 50567-7

When using this product Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Directions

WET HANS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING

FOR children under , use only under adult supervision

Not recommedned for infants

Do Not Use

In children less than 2 months of age.

Other Information

Do not store above 105℉FMay discolor some fabricsHarmful to wood finishesand plastics

When using this product: Keepout of eyes. Iin case of contactwith eyes, flush thoroughly withwater. e Do not inhale or ingest.Avoid contact with broken skin.

Active Ingredient(s)

ETHYL ALCOHOL 62%

Inactive Ingredients

Water (Aqua), Acrylates/C10-30Alkyl Acrylate Crosspolymer,PEG-40Hydrogenated Castor 0il.

Package Label Principal Display Panel

Structured Label Content

Use

Uses To decrease bacteria andgerms on the skin Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of chlldren. If swallowed. get medical help or contact a Polson Control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be sians of a serious condition.

Section 50567-7 (50567-7)

When using this product Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Directions

WET HANS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING

FOR children under , use only under adult supervision

Not recommedned for infants

Do Not Use (Do not use)

In children less than 2 months of age.

Other Information (Other information)

Do not store above 105℉FMay discolor some fabricsHarmful to wood finishesand plastics

When using this product: Keepout of eyes. Iin case of contactwith eyes, flush thoroughly withwater. e Do not inhale or ingest.Avoid contact with broken skin.

Active Ingredient(s)

ETHYL ALCOHOL 62%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Acrylates/C10-30Alkyl Acrylate Crosspolymer,PEG-40Hydrogenated Castor 0il.

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

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)", "unii": "8Z5ZAL5H3V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-40 CASTOR OIL", "unii": "4ERD2076EF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEMON PEEL", "unii": "72O054U628", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Uses To decrease bacteria andgerms on the skin Recommended for repeated use.", "50565-1": "Keep out of reach of chlldren. If swallowed. get medical help or contact a Polson Control center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be sians of a serious condition.", "50567-7": "When using this product Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "WET HANS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING FOR children under , use only under adult supervision Not recommedned for infants", "Do not use": "In children less than 2 months of age.", "Other information": "Do not store above 105℉FMay discolor some fabricsHarmful to wood finishesand plastics When using this product: Keepout of eyes. Iin case of contactwith eyes, flush thoroughly withwater. e Do not inhale or ingest.Avoid contact with broken skin.", "Active Ingredient(s)": "ETHYL ALCOHOL 62%", "Inactive ingredients": "Water (Aqua), Acrylates/C10-30Alkyl Acrylate Crosspolymer,PEG-40Hydrogenated Castor 0il."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.820550 · Updated: 2026-03-14T23:02:36.495120