Gentlehands Antiseptic Hand Sanitizer
FDA Label NDC 79109-700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roldan Industries for the product Gentlehands Antiseptic Hand Sanitizer (NDC 79109-700). 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, use, 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 70%
Purpose
Antiseptic
Use
• 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 us e only
Do not use
• in children less than 2 months of age
• open skin wounds
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
• irritation and redness develop
• condition persists for more than 72 hours.
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
carbomer, EDTA, glycerol, polysorbate, triethanolamine, water
Questions? +1-786-843-1308
You may also report serious side effects to this phone number. Mon - Fri 9:00 AM - 5:00 PM
Other
LOT NO. AND EXPIRY
PRINTED ON BOTTLE
Distributed by: Roldan Industries
1500 E Tropicana Ave. Ste 154 Las Vegas NV 89119
COUNTRY OF ORIGIN: MEXICO
Packaging
Untitled (79109 700)
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