SPL v4
SPL
SPL Set ID a3f42a32-aed8-44f1-e053-2a95a90a5a0c
Route
TOPICAL
Published
Effective Date 2021-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 mL)
Inactive Ingredients
Edetol Aloe Vera Leaf Water Carbomer Interpolymer Type A (55000 Cps)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-01
Description

Ethyl Alcohol 65%

Purpose

Antiseptic hand sanitizer

Medication Information

Purpose

Antiseptic hand sanitizer

Description

Ethyl Alcohol 65%

Uses

For hand sanitizing to decrease bacteria on skin

Recommended for repeated use

Section 51945-4

Warnings

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

When using this product: Avoid contact with eyes.In case of eye contact, flush eyes with water.

Stop use and ask a doctor if: irritation or redness develops,or if condition persists for more than 72 hours.

Directions

Squeeze appropriate amount of sanitizer on to hands and rub together until dry.

Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

Active Ingredient

Ethyl Alcohol 65%

Inactive Ingredients

ALOE BARBADENSIS LEAF EXTRACT, WATER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,TETRAHYDROXYPROPYL ETHYLENEDIAMINE

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel

118mL NDC: 75821-001-01

236mL NDC: 75821-001-02

Structured Label Content

Uses (USES)

For hand sanitizing to decrease bacteria on skin

Recommended for repeated use

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Antiseptic hand sanitizer

Warnings (WARNINGS)

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

When using this product: Avoid contact with eyes.In case of eye contact, flush eyes with water.

Stop use and ask a doctor if: irritation or redness develops,or if condition persists for more than 72 hours.

Directions (DIRECTIONS)

Squeeze appropriate amount of sanitizer on to hands and rub together until dry.

Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 65%

Inactive Ingredients (INACTIVE INGREDIENTS)

ALOE BARBADENSIS LEAF EXTRACT, WATER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,TETRAHYDROXYPROPYL ETHYLENEDIAMINE

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel (PACKAGE LABEL - PRINCIPAL DISPLAY PANEL)

118mL NDC: 75821-001-01

236mL NDC: 75821-001-02

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:22.277520 · Updated: 2026-03-14T22:59:17.868516