Otc - Active Ingredient
Active Ingredient Purpose
Benzalkonium Chloride 0.13% .......... Antimicrobial
Xtracare Foaming Hand Sanitizer Gel
FDA Label NDC 57337-057
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare Foaming Hand Sanitizer (NDC 57337-057). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use:
to help reduce bacteria on the skin
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Indications & Usage
XtraCare® Foaming Hand Sanitizer
Superior Protection
Alcohol Free
Kills 99.9% of germs
Clean Fresh Scent
7 FL OZ (207 mL)
Warnings
Warnings: for external use only.
When using this product Avoid contact with eyes. In case of eye contact, flush with plenty of water. Avoid contact with broken skin.
Stop use and ask a doctor if skin iffitation develops.
Dosage & Administration
Directions
wet hands thoroughly with product and rub into skin until dry.
For children under 6, use only under adult supervision.
Not recommended for infancts.
Inactive Ingredient
Inactive Ingredients: water, cetrimonium chloride, disodium cocoamphodiacetate, fragrance, glycerin, citric acid, dimethicone, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.
Other Safety Information
Questions/Comments? 1-855-345-5575
DISTRIBUTED BY:
REJOICE INTERNATIONAL INC
NORTHVILLE, MI 48168 USA
MADE IN CHINA
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