SPL v1
SPL
SPL Set ID 7ddf39ba-d73e-40cd-a37c-542a8939bd65
Route
TOPICAL
Published
Effective Date 2020-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Isopropyl Myristate Polyethylene Glycol 300 Adenosine Phosphate Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%) Alpha-tocopherol Acetate Dipropylene Glycol 1-(2,3,8,8-tetramethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-yl)ethanone Linalyl Acetate Linalool, (+/-)- Ethylene Brassylate Ethyl Linalool 2-isobutyl-4-methyltetrahydropyran-4-ol Bergamot Oil 3-hexenyl Salicylate, Cis- Butylated Hydroxytoluene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-08
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.

Section 50565-1

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

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.

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 20-250C(68-770F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Water, Fragrance (Parfum), Glycerin, lsopropyl Myristate, PEG-6 & AMP Acrylates I Vinyl lsodecanoate Crosspolymer, Tocopheryl Acetate.

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.

Section 50565-1 (50565-1)

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

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.

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 (Other information)
  • Store at 20-250C(68-770F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Water, Fragrance (Parfum), Glycerin, lsopropyl Myristate, PEG-6 & AMP Acrylates I Vinyl lsodecanoate Crosspolymer, Tocopheryl Acetate.

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: 2026-02-15T11:58:05.421981 · Updated: 2026-03-14T22:57:27.471846