SPL v2
SPL
SPL Set ID 4ef3c800-1754-4d9c-81d6-5309db7b04cf
Route
TOPICAL
Published
Effective Date 2024-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

Alcohol 80% v/v

Purpose

Antiseptic & Antibacterial


Medication Information

Purpose

Antiseptic & Antibacterial

Description

Alcohol 80% v/v

Use[s]

Sanitizing wipe to help reduce bacteria that potentially can cause disease. 

Warnings

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

Directions
  • Wipe hands or all surfaces. Allow to 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
  • Do not re-use wipes
Drug Facts

Product Label

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F )
  • use fresh wipe if your wipe becomes solid or dry
  • Make sure to wet surface completely
  • Allow surface to dry before use
Active Ingredient[s]

Alcohol 80% v/v

Inactive Ingredients

Glycerin, Hydrogen peroxide, Purified Water USP.

When Using This Product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Keep Out of Reach of Children.

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


Structured Label Content

Use[s]

Sanitizing wipe to help reduce bacteria that potentially can cause disease. 

Purpose

Antiseptic & Antibacterial

Warnings

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

Directions
  • Wipe hands or all surfaces. Allow to 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
  • Do not re-use wipes
Drug Facts

Product Label (Product label)

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F )
  • use fresh wipe if your wipe becomes solid or dry
  • Make sure to wet surface completely
  • Allow surface to dry before use
Active Ingredient[s] (Active ingredient[s])

Alcohol 80% v/v

Inactive Ingredients (Inactive ingredients)

Glycerin, Hydrogen peroxide, Purified Water USP.

When Using This Product (When using this product)

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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