Dextragel Antiseptic Hand Sanitizer
FDA Label NDC 80209-098
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dextra Gel, Llc for the product Dextragel Antiseptic Hand Sanitizer (NDC 80209-098). 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 drug facts, active ingredient, purpose, uses, warnings, 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
Active Ingredient
Ethyl alcohol 75% v/v
Purpose
Antiseptic
Uses
- hand sanitizer to decrease bacteria on the skin
- recommended for repeated use
- for use when soap and water are not available
Warnings
Flammable, keep away from fire/flame
For external use only
Do not use
- in children less than 2 months of age
- on open skin wounds
- irritation and redness develop
- condition persists for more than 72 hours
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
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
- wet hands thoroughly with product and allow to dry without wiping
- supervise children under 6 years of age when using this product to avoid swallowing
Other Information
- store between 15-30°C (59-86˚F)
- avoid freezing and excessive heat above 40˚C (104˚F)
Inactive Ingredients
glycerin, carbomer, triethanolamine, water
Questions? +1-888-385-4685
You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM
Other
CONVENIENT EASY TO TEAR PACKETS
Clean Hands on the Go
A Simple Decision in an Uncertain World
Our convenient sanitizer packets provide the highest level of clean when soap and water are not within reach.
Each packet fits in the palm of your hand, providing a 2 mL measured amount. The easy tear packet allows for quick sanitizing and disposal for your valued customers, keeping them and their families safe.
Easy Tear Packs
Nontoxic
Distributed by: Dextragel LLC - Kennedale, TX 76060
Country of origin: China
www.dextragel.com
Packaging
Image (8020909830)
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