26b8c4f7-6c31-42dc-8066-e733eadab190

SPL v4
SPL
SPL Set ID 26b8c4f7-6c31-42dc-8066-e733eadab190
Route
topical
Published
Effective Date 2020-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
water glycerin carbomer homopolymer type c (allyl pentaerythritol crosslinked) aminomethylpropanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-05-26

Purpose

Antiseptic

Description

Alcohol 75% v/v.


Medication Information

Warnings

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

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this productkeep out 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.

Uses

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

Purpose

Antiseptic

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.

Other information

  • Store between 59-86 0F (15-30 0C)
  • Avoid freezing and excecssive heat above 104 0F (40 0C)
Inactive Ingredients

Description

Alcohol 75% v/v.

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Alcohol 75% v/v.

Package Label Principal Display Panel


Structured Label Content

Warnings

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

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this productkeep out 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.

Uses

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

Purpose

Antiseptic

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.

Other information

  • Store between 59-86 0F (15-30 0C)
  • Avoid freezing and excecssive heat above 104 0F (40 0C)
Inactive Ingredients (Inactive ingredients)

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Alcohol 75% v/v.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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