SPL v1
SPL
SPL Set ID d032e714-148e-404d-b142-3ff9487385cc
Route
TOPICAL
Published
Effective Date 2021-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-10-07

Description

Alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v

Uses

Use hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

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

Do not use

• On children less than 2 months of age

• On open skin wound

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if irritation occurs. These may be

signs of a serious condition.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using the product to avoid swallowing.

Drug Facts

Product Label

Active Ingredient

Alcohol 70% v/v

Other Information

*Store between 15-30C (59-86F)

*Avoid freezing and excessive heat about 40C (104F)

Inactive Ingredients

carbomer, fragrance, glycerin, water

Keep Out of Reach of Children

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


Structured Label Content

Uses

Use hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Purpose

Antiseptic

Warnings

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

Do not use

• On children less than 2 months of age

• On open skin wound

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if irritation occurs. These may be

signs of a serious condition.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using the product to avoid swallowing.

Drug Facts

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 about 40C (104F)

Inactive Ingredients

carbomer, fragrance, glycerin, water

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)