Piperwaihandsanitizerlemongrass
FDA Label NDC 81741-110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Piperwai, Llc for the product Piperwaihandsanitizerlemongrass (NDC 81741-110). 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 rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand rub 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) (62%,) 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)

Ethyl Alcohol 62%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Rub

Use

Reduces the amount of bacteria on hands. Recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do Not Use

  • aviod contact with eyes.
  • In case of contact, flush thoroughly with water.

Otc - When Using

When using this product aviod contact with eyes. In case of contact, flush thoroughly with water.
Stop use and ask a doctor if irritation occurs. 

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. 

Otc - Keep Out Of Reach Of Children

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

Directions

  • Pump onto dry hands as needed coating evenly.
  • Allow to dry without wiping
  • Supervise children under 6 years old
  • Not recommended for infants.

Other Information

Do not store above 105F

Inactive Ingredients

Water, Glycerin, Aloe Barbadensis Leaf Juice, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Mentha Piperita (Peppermint) Oil, Aminomethyl Propanol

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