Nivana Hand Sanitizer
FDA Label NDC 78554-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dinasty Inc. for the product Nivana Hand Sanitizer (NDC 78554-005). 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 ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Ethanol (Ethyl Alcohol)75%v/v

Purpose

Antiseptic

Use

to help reduce bacteria on the skin that could potentially cause disease

Warnings

Flammable, keep away from fire or flame.

For external use only:hands

When Using This Product

  • do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor If

irritation or rash appears and lasts

Keep Out Of Reach Of Children.

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

Directions

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age, use only under adult supervision
  • not recommended for infants

Other Information

  • Store below 104°F (40°C)
  • May discolor certain fabrics or surfaces

Inactive Ingredients

Purified water USP, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Aloe Barbadensis (Aloe Vera) Gel, Tocopheryl Acetate (Vitamin E)

Package Labeling:

Bottle2 (Bottle2)

Bottle2 (Bottle2)

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