Handsanitizer
FDA Label NDC 90108-050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bathletix for the product Handsanitizer (NDC 90108-050). 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, uses, warnings, do not use, when using this product, otc - stop use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Uses

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

Warnings

  • For external use only
  • Flammable. 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.

Otc - Stop Use

Stop use and ask 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.

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 at temperature below 110°F

Inactive Ingredients

*Water, Glycerin, Hydroxypropyl Guar, Citric Acid, Calendula Officinalis Flower Extract, Chomomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice.

Principal Display Panel – 30 Ml Bottle Label

Bathletix®
HAND
SANITIZER

ANTI-BACTERIAL GEL
WITH ALOE VERA

KILLS 99.9%
OF GERMS

1 fl.oz./30ml

Figure (Bat01 0000 01)

Figure (Bat01 0000 01)

* Please review the disclaimer below.