SPL v1
SPL
SPL Set ID a9f4384c-ac2c-6d91-e053-2a95a90a5e1c
Route
TOPICAL
Published
Effective Date 2020-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.01 g)
Inactive Ingredients
Propylene Glycol Water Hypromelloses Tea Tree Oil Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-08
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.

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.

Display Panel

Label

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] (USE[S])

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

Purpose (PURPOSE)

Antiseptic

Stop Use (STOP USE)

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

Warnings (WARNINGS)

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

Directions (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.

Display Panel (DISPLAY PANEL)

Label

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

Alcohol 70% v/v

Inactive Ingredients (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: 2026-02-15T11:58:09.146934 · Updated: 2026-03-14T22:57:34.491747