Cleansepure

Cleansepure
SPL v2
SPL
SPL Set ID f517bc9d-f35e-4a56-ab36-51554fa26c0c
Route
TOPICAL
Published
Effective Date 2020-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer, Unspecified Type Aloe Vera Leaf Trolamine Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-18
Description

Alcohol 70% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v.

Use[s]

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

Section 42229-5

NON-STERILE SOLUTION

Made in Mexico.

Imported by:

Frozen Wheels, LLC

16565 NW 15th Ave.

Miami, FL 33169

Distributed by:

Distribu LLC

Section 50565-1

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

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

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

Packaging

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.
Drug Facts

Active Ingredient

Alcohol 70% v/v.

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

demineralized water, glycerin, carbomer, aloe vera extract, triethanolamine, disodium EDTA.

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.

Section 42229-5 (42229-5)

NON-STERILE SOLUTION

Made in Mexico.

Imported by:

Frozen Wheels, LLC

16565 NW 15th Ave.

Miami, FL 33169

Distributed by:

Distribu LLC

Section 50565-1 (50565-1)

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

Purpose

Antiseptic

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

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

Packaging

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.
Drug Facts

Active Ingredient (Active ingredient)

Alcohol 70% v/v.

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

demineralized water, glycerin, carbomer, aloe vera extract, triethanolamine, disodium EDTA.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:49.012468 · Updated: 2026-03-14T22:57:06.397974