SPL v1
SPL
SPL Set ID 37feef1f-a0d1-5fb2-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-07-18
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 Carbomer Interpolymer Type A (55000 Cps) Fd&c Yellow No. 5 Aminomethylpropanol Lactose Cellulose, Microcrystalline Sucrose Starch, Corn Ultramarine Blue .alpha.-tocopherol Acetate Hypromelloses Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-07-18
Description

Active Ingredient: Ethyl Alcohol 62%

Medication Information

Warnings and Precautions

Warnings For external use only. Flammable. Keep away from fire or flame.

Indications and Usage

Uses To help reduce bacteria on the skin.

Dosage and Administration

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

Description

Active Ingredient: Ethyl Alcohol 62%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51727-6

Inactive Ingredients Water, Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Red No.4, FD&C Yellow No.5.

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 To help reduce bacteria on the skin.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings For external use only. Flammable. Keep away from fire or flame.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51727-6 (51727-6)

Inactive Ingredients Water, Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Red No.4, FD&C Yellow No.5.

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: 2026-02-15T11:56:08.624733 · Updated: 2026-03-14T22:54:23.335310