SPL v1
SPL
SPL Set ID a4b28e3c-b7e4-b30a-e053-2995a90a795a
Route
TOPICAL
Published
Effective Date 2020-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.0075 g)
Inactive Ingredients
Hypromelloses Lavender Oil Glycerin Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-02

Description

Alcohol 65%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 65%

Use[s]

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

Package

Front Label

Stop Use

Stop use section and ask a doctor if irritation or rash occurs.

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 age of 6 when using this product to avoid swallowing.
Do Not Use

Do not use

  • On children less than 2 months of age.
  • On open skin wounds.
When Using

When using this product keep out of eyes, ears, mouth. In case of contact with eyes, rinse 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 65%

Inactive Ingredients

Water (Aqua), Propylene Glycol, Glycerin, Methyl hydroxypropyl Cellulose, Lavandula Angustifolia (lavender 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.


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

Front Label

Purpose

Antiseptic

Stop Use (Stop use)

Stop use section and ask a doctor if irritation or rash occurs.

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 age of 6 when using this product to avoid swallowing.
Do Not Use (Do not use)

Do not use

  • On children less than 2 months of age.
  • On open skin wounds.
When Using (When using)

When using this product keep out of eyes, ears, mouth. In case of contact with eyes, rinse 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 65%

Inactive Ingredients

Water (Aqua), Propylene Glycol, Glycerin, Methyl hydroxypropyl Cellulose, Lavandula Angustifolia (lavender Oil)

Keep Out of Reach of Children (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

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