SPL v1
SPL
SPL Set ID c4a67d07-16ca-4e83-b288-3b0d6031b125
Route
TOPICAL
Published
Effective Date 2020-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (.80 1)
Inactive Ingredients
Glycerin Polysorbate 20 Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-01
Description

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 80% v/v. Purpose: Antiseptic

Uses:

To decrease bacteria and sanitize surfaces

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

Stop use and ask a doctor if irritation and redness develop. Condition persist for more than 72 hours.

Section 50567-7

When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water, avoid contact with broken skin.

Section 51945-4

Warnings:

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

Directions:

Open cap on canister, pull sheet up slightly to side.  Use on hands and non-porous surfaces.  For children under 6, use adult supervision, not recommended for infants.

Other Information:

Do not store above 105F.  May be harmful to wood surfaces and plastic.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients:

Fragrance, Glycerin, Polysorbate-20, Propylene Glycol, Water

Structured Label Content

Uses:

To decrease bacteria and sanitize surfaces

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)

Stop use and ask a doctor if irritation and redness develop. Condition persist for more than 72 hours.

Section 50567-7 (50567-7)

When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water, avoid contact with broken skin.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings:

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

Directions:

Open cap on canister, pull sheet up slightly to side.  Use on hands and non-porous surfaces.  For children under 6, use adult supervision, not recommended for infants.

Other Information:

Do not store above 105F.  May be harmful to wood surfaces and plastic.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients: (Inactive ingredients:)

Fragrance, Glycerin, Polysorbate-20, Propylene Glycol, Water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:14.257025 · Updated: 2026-03-14T22:59:07.764303