Caren Hand Sanitizer Antiseptic
FDA Label NDC 77009-0420

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Caren Products, Llc for the product Caren Hand Sanitizer Antiseptic (NDC 77009-0420). 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 active ingredient(s), purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Benzalkonium Chloride....................Purpose: Antimicrobial and First Aid Antiseptic

Purpose

Antimicrobial and First Aid Antiseptic

Uses

  • For hand sanitizing to decrease bacteria on the skin.  Recommended for repeated use.  
  • For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations, and sking infections.

Warnings

For external use only.

Otc - When Using

When using this product avoid contact with eyes.  In case of eye contact, flush eyes with water.

Otc - Stop Use

Discontinue use if irratation or redness develops.  If condition persists for more than 72 hours consult a doctor.

Otc - 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.

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.
  • Antiseptic: Apply to cuts, scrapes, and burns 3 times a day after cleaning.  Allow to dry.

Inactive Ingredients

Aloe, Carbomer, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Purified Water

Package Label - Principal Display Panel

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