Sd Kleen Rx Antiseptic Hand Rub
FDA Label NDC 79147-000

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 Antiseptic Hand Rub (NDC 79147-000). 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, 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.

Active Ingredient(S)

Alcohol 80% v/v

Purpose

Antiseptic

Use(S)

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

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 6 years of age when using this product to avoid swallowing.

Other Information

- Store between 10-30 °C (59-85°F)

- Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

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