SPL v1
SPL
SPL Set ID a62f0288-49c8-64dd-e053-2995a90a075a
Route
TOPICAL
Published
Effective Date 2020-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.233 g)
Inactive Ingredients
Water Tea Tree Oil Glycerin Propylene Glycol Hypromelloses

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-21
Description

Alcohol 70% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Package

Full Package label

Stop Use

If irritation or rash occurs. These may be signs of a serious condition.

Warnings

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

Directions
  • Place enough product on hands to cover all surfaces.
  • Rub hands together until dry.
  • Supervise children under 6 years of age.
  • When using this product avoid swallowing.
Do Not Use
  • On children less than 2 months of age.
  • On open skin wounds.
When Using

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Other Information
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
Active Ingredient[s]

Alcohol 70% v/v

Inactive Ingredients

Water (Aqua), Propylene Glycol, Glycerin, Methyl Hydroxypropyl Cellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

Keep Out of Reach of Children

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

Structured Label Content

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Package

Full Package label

Purpose

Antiseptic

Stop Use (Stop use)

If irritation or rash occurs. These may be signs of a serious condition.

Warnings

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

Directions
  • Place enough product on hands to cover all surfaces.
  • Rub hands together until dry.
  • Supervise children under 6 years of age.
  • When using this product avoid swallowing.
Do Not Use (Do not use)
  • On children less than 2 months of age.
  • On open skin wounds.
When Using (When using)

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Other Information
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
Active Ingredient[s]

Alcohol 70% v/v

Inactive Ingredients

Water (Aqua), Propylene Glycol, Glycerin, Methyl Hydroxypropyl Cellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:40.683637 · Updated: 2026-03-14T22:56:53.457681