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Drug Facts
Manufactured for Inopak, LTD., Ringwood, NJ 07456
1-800-762-7725 • www.inopak.com
Dermagel
FDA Label NDC 58575-231
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Inopak. Ltd for the product Dermagel (NDC 58575-231). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - 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
Otc - Active Ingredient
Active Ingredient
Alcohol 70% v/v
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Uses
- to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment
- recommended for repeated use.
Warnings
Warnings
For external use only
Flammable. Keep away from heat or flame.
Otc - When Using
When using this product keep away from eyes. In case of eye contact, flush with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, contact a physician or poison control center.
Dosage & Administration
Directions
- apply liberally to hands to cover all surfaces
- rub hands together until dry
- supervise children under 6 years old
- not recommended for infants
Inactive Ingredient
Ingredients Water, Glycerin, Propylene Glycol, Isopropy Myristate, Aloe Barbedensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Carbomer, Triisopropanolamine
Package Label.Principal Display Panel
DermaGel®
HAND SANITIZING GEL with moisturizers
70% Alcohol with ALOE VERA & VITAMIN E
KILLS 99.99% OF GERMS!
NET CONTENTS: 800 ML (27 FL. OZ.)
* Please review the disclaimer below.
