Sd Kleen Rx Hand Sanitizer
FDA Label NDC 79147-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spa Dent Inc. for the product Sd Kleen Rx Hand Sanitizer (NDC 79147-002). 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, purpose, use(s), warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Use(S)

• Antiseptic (skin) cleanser • Medicated (skin) cleanser • Antibacterial (skin) cleanser • Effective in destroying (harmful) bacteria to provide antiseptic cleansing • For personal hand hygiene to help prevent the spread of bacteria

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, rise eyes thoroughly with water.

Stop Use And Ask A Doctor

if irritation or rash occurs. These may be signs of a serious condition.

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.

Other Information

  • Store between 15° - 30 °C (59° - 85°F) out of direct sunlight.
  • Avoid freezing and excessive heat above 40° C (104° F).

    • Do not use this product if tamper-resistant seal is broken when opened.

Inactive Ingredients

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Aloe barbadensis Leaf Juice, dl-alpha Tocopheryl acetate

Package Labeling:

Bottle3 (Bottle3)

Bottle3 (Bottle3)

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