Dewmed Instant Antibacterial Cleansing Hand Sanitizer
FDA Label NDC 80065-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dewmed Llc for the product Dewmed Instant Antibacterial Cleansing Hand Sanitizer (NDC 80065-001). 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 drug facts, active ingredients, purpose, directions, uses, warnings, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

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.

Uses

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. 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, 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Water (Aqua), Polyquaternium-37, Glycerin, Panthenol, Niacinamide, Polysorbate 20, Tocopheryl Acetate, Pelargonium Graveolens (Rose Geranium) Flower Oil, Tagetes Minuta (Wild Marigold) Flower Extract, Rosa Damascena (Rose Otto) Flower Oil, Jasminum Officinale (Jasmine) Flower Extract, Citrus Aurantinum (Neroli) Flower Oil, Propylene Glycol, Benzyl Alcohol, Methlchloroisothiazolinone, Methylisothiazolinone, FD&C Blue 1.

Other Information

Store between 15-30°C (59-86F).
Avoid freezing and excessive heat above 40°C (104F).

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

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