SPL v3
SPL
SPL Set ID 2cfd69ae-2557-4895-8627-d93bcf1b80c9
Route
TOPICAL
Published
Effective Date 2020-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Polyethylene Glycol 300 Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%) Glycerin Isopropyl Myristate Polyethylene Terephthalate (intrinsic Viscosity 0.70-1.00) Polylactide Dipropylene Glycol 3a,4,5,6,7,7a-hexahydro-1h-4,7-methanoinden-6-yl Acetate Terpinyl Acetate Rosemary Oil Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-03
Description

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

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

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

Directions

•Wet hands.

•Briskly rub hands together until dry.

•Supervise children in the use of this product.

Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information

•Store at 20-25C(68-77F)

•Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Glycerin, Isopropyl Myristate, PEG-6 & AMP Acrylates/Vinyl Isodecanoate Crosspolymer, Tocopheryl Acetate, Glitter, Fragrance.

Package Label  principal Display Panel

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

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

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

Directions

•Wet hands.

•Briskly rub hands together until dry.

•Supervise children in the use of this product.

Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information

•Store at 20-25C(68-77F)

•Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Glycerin, Isopropyl Myristate, PEG-6 & AMP Acrylates/Vinyl Isodecanoate Crosspolymer, Tocopheryl Acetate, Glitter, Fragrance.

Package Label  principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:22.738762 · Updated: 2026-03-14T23:00:46.071932