Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 01d44078-4bcd-408b-87ea-7a92b0a51dc5
Route
TOPICAL
Published
Effective Date 2021-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer Type C Trolamine Human Thymus

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-20

Description

Alcohol 70% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

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.

Section 50567-7

When using this products keepout of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation or rash occurs. These may be signs of a serious condition.

Warnings

For external use only. Flammable. Keep out of reach of children.

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 to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Product Label

Active Ingredient

Alcohol 70% v/v.

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Carbomer, Glycerin, Purified Water, Thymus Essential Oil, Triethanolamine


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.

Section 50567-7 (50567-7)

When using this products keepout of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation or rash occurs. These may be signs of a serious condition.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep out of reach of children.

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 to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Product Label (Product label)

Active Ingredient

Alcohol 70% v/v.

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Carbomer, Glycerin, Purified Water, Thymus Essential Oil, Triethanolamine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)