Active Ingredient(S)
Ethyl Alcohol 75% Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 61924-114
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermarite Industries, Llc for the product Hand Sanitizer (NDC 61924-114). 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 ingredient(s), purpose, use, warnings, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer
Use
For cleansing/sanitizing of the hands when soap and water are not available.
Recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat or flame. Avoid contact with eyes. In case of contact, flush thoroughly with water. Stop use and seek medical attention if skin irritation develops.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.
Directions
Apply Generously, work into hands and allow to dry without wiping.
Children under six should be supervised while using this product.
Other Information
- Do not store above 110F
- May discolor some fabrics or surfaces.
- Report adverse events to DermaRite Industries, PO box 7209, North Bergen, NJ 07047
Inactive Ingredients
Deionized Water, glycerol, Carbomer, Triethanolamine
Questions?
Call 1-800-337-6296
Mon-Fri 9AM- 5PM EST.
Package Label - Principal Display Panel
8 oz NDC: 61924-114-08
* Please review the disclaimer below.
