Durashield Fragrance Free Hand Sanitizer
FDA Label NDC 78235-012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ck Polymers Llc for the product Durashield Fragrance Free Hand Sanitizer (NDC 78235-012). 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 ingredients, purpose, use, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Active Ingredients: Benzalkonium chloride 0.13% 

Purpose

Purpose: hand sanitizer

Use

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

Warnings

For external use only.

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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 (59-86°F)

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

Inactive Ingredients

water, corn starch, soybean oil, petrolatum, pectin, xanthan gum, citricidal, tributyl phosphate, methyl paraben, propyl paraben, vitamin E acetate, white linen fragrance

Inactive Ingredient

Questions

275 Gallon Tote - Durashield® Fragrance Free Hand Sanitizer - Label

Nat-275-gallon-tote-2 (275 Label 2)

Nat-275-gallon-tote-2 (275 Label 2)

55 Gallon Drum - Durashield® Fragrance Free Hand Sanitizer - Label

55-label-2 (55 Label 2)

55-label-2 (55 Label 2)

330 Gallon Tote - Durashield® Fragrance Free - Label

330-label-2 (330 Label 2)

330-label-2 (330 Label 2)

5 Gallon Pail - Durashield® Fragrance Free Hand Sanitizer - Label

5-label-2 (5 Label 2)

5-label-2 (5 Label 2)

* Please review the disclaimer below.