SPL v1
SPL
SPL Set ID 912eeb77-503c-48ec-e053-2995a90ada62
Route
TOPICAL
Published
Effective Date 2019-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
.alpha.-tocopherol Maltodextrin Aloe Vera Leaf Water Glycerin Propylene Glycol Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-08-28
Description

Active Ingredients: Ethanol 62%

Medication Information

Warnings and Precautions

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not use in the eyes.

Indications and Usage

Use

To decrease bacteria on the skin .

Dosage and Administration

Directions

Rub into skin until dry.

Description

Active Ingredients: Ethanol 62%

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

Discontinue use if irritation or redness develop. If condition persists for more that 72 hours, consult a doctor.

Section 51727-6

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Vitamin E, Glycerin, Propylene Glycol, Fragrance, Acrylates/C10-C30 alkyl acrylate crosspolymer, Triethanolamine.

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredients:

Ethanol 62%

Section 60561-8

Other Information

Store below 110F. Avoid direct sunlight, fluorescent lightning,heat and moisture.

Structured Label Content

Indications and Usage (34067-9)

Use

To decrease bacteria on the skin .

Dosage and Administration (34068-7)

Directions

Rub into skin until dry.

Warnings and Precautions (34071-1)

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not use in the eyes.

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)

Discontinue use if irritation or redness develop. If condition persists for more that 72 hours, consult a doctor.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Vitamin E, Glycerin, Propylene Glycol, Fragrance, Acrylates/C10-C30 alkyl acrylate crosspolymer, Triethanolamine.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredients:

Ethanol 62%

Section 60561-8 (60561-8)

Other Information

Store below 110F. Avoid direct sunlight, fluorescent lightning,heat and moisture.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:51.059688 · Updated: 2026-03-14T22:55:36.629297