Hand Sanitizerportcall
FDA Label NDC 76650-119

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genesis Salon Products Llc for the product Hand Sanitizerportcall (NDC 76650-119). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol
  • Sterile distilled water.

Active Ingredient(S)

Alcohol 70%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire and flame

Do Not Use

  • Do not use in or near eyes.

Otc - When Using

When using this product do not use in or ner eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts. 
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs 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 together briskly until dry.

Children under 6 years of age should be supervised when using this product

Other Information

  • Store below 110F (43C).
  • May discolor certain fabrics or surfaces.

Inactive Ingredients

Deionized water, glycerin, polysorbate 20, aloe barbadensis leaf juice, citrus aurantium dulcis peel oil, tocopheryl acetate, maltodextrin, parfum

Package Label - Principal Display Panel

Image Description (Portcall Sanitizer)

Image Description (Portcall Sanitizer)

* Please review the disclaimer below.