SPL v1
SPL
SPL Set ID 403dc1ab-6a4e-0e26-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Aloe Vera Leaf Glycerin Propylene Glycol D&c Red No. 33 Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-11-01
Description

Active Ingredient Ethyl Alcohol 62%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Indications and Usage

Uses

Decrease bacteria on hands

Dosage and Administration

Directions:

Pump as needed into your palms to cover hands. Rub hands together briskly until dry.

Description

Active Ingredient Ethyl Alcohol 62%

Section 50565-1

Keep it out of children.

Section 50566-9

Stop use and ask a doctor if irritation or redness develops. If swallowed, get medical help or contact a doctor right away.

Section 51727-6

Inactive Ingredients

Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, FD&C Red No.4, D&C Red No.33

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 62%

Structured Label Content

Indications and Usage (34067-9)

Uses

Decrease bacteria on hands

Dosage and Administration (34068-7)

Directions:

Pump as needed into your palms to cover hands. Rub hands together briskly until dry.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Section 50565-1 (50565-1)

Keep it out of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops. If swallowed, get medical help or contact a doctor right away.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, FD&C Red No.4, D&C Red No.33

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 62%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:12.685990 · Updated: 2026-03-14T22:54:30.332332