Antibacterial Skin Cleanser 82
FDA Label NDC 42497-822

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Penco Products, Inc. for the product Antibacterial Skin Cleanser 82 (NDC 42497-822). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active IngredientChloroxylenol 1% w/w

Otc - Purpose

PurposeHealth Care Personnel Hand Wash

Indications & Usage

Uses
  • Hand Wash to help reduce bacteria that cause disease
  • Repeated usage suggested

Warnings

WarningsFor external use only.Keep out of reach of children.Avoid contact with eyes and mouth.If redness or irritation develops, discontinue use immediately.  If condition persists for more than 72 hours, consult a physician.Not for use on children under 6 months of age.

Dosage & Administration

Directions
  • Wash hands and forearms.
  • Apply 5 mL of product to hands.
  • Scrub well for 30 seconds.
  • Rinse and repeat.

Inactive Ingredient

Inactive IngredientsWater, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene Acrylates/Copolymer, Tetrasodium EDTA, Citric Acid

Otc - Questions

In Case of EmergencyCall: (800) 228-5635  ext. 167

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