Proclean Hand Sanitizer
FDA Label NDC 77110-220

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biominerales Pharma for the product Proclean Hand Sanitizer (NDC 77110-220). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, inactive ingredients, use(s), warnings, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

Active Ingredient

Isopropyl Achohol 70%

Purpose

Antiseptic

Inactive Ingredients

Water (aqua), carbomer, glycerin, propylene glycol, hydrogen peroxide, aminomethyl propanol

Use(S)

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

Warnings

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

Otc - Do Not Use

Do not use in children less than 2 months of age or on open skin wounds.

Otc - When Using

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

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

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

Principal Display Panel - 3.79 L Bottle Label

PROCLEAN

HAND SANITIZER GEL

This product should be used as part
of the daily hand cleansing routine

70% ISOPROPYL ALCOHOL
Fights germs and bacteria

1 GAL (3.79 L)

MADE IN CANADA
NDC#77110-220-01

Principal Display Panel (3.79 L Bottle Label)

Principal Display Panel (3.79 L Bottle Label)

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