Mani Spa Guard Advanced Hand Sanitizer
FDA Label NDC 77591-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pedisource for the product Mani Spa Guard Advanced Hand Sanitizer (NDC 77591-002). 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
Alcohol 70% 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
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
water, glycerin, aloe barbadensis leaf juice, tocopheryl acetate, polyacrylate crosspolymer, fragrance
Questions?
+1-856-320-6927
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM
Other
MADE IN * * * THE USA
• ALCOHOL 70% • GEL FORMULA
• WITH ALOE VERA & VITAMIN E
Manufactured by: PediSource LLC, Cinnaminson, NJ, 08077
www.ManiSpaGuard.co m
Packaging
Untitled (Label)
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