Otc - Active Ingredient
DRUG FACTS
Active Ingredients Purpose
Ethyl Alcohol 62% Antiseptic
Sugar Cookies Scented Antibacterial Hand Sanitizer
FDA Label NDC 50563-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Enchante Accessories for the product Sugar Cookies Scented Antibacterial Hand Sanitizer (NDC 50563-201). 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, warnings, otc - stop use, dosage & administration, information for patients, inactive ingredient, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
To decrease bacteria on the skin that could cause disease
Recommended for repeated use.
Warnings
Warnings:
For external use only-hands.
Flammable
Keep away from heat and flame.
When using this product
Keep out of eyes. In case of contact with eyes, flush thoroughly with water
Avoid contact with broken skin
Do not inhale or ingest
Otc - Stop Use
Stop use and ask a doctor if skin irritation develops.
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a poison control center immediately
Dosage & Administration
Directions
Wet hands thoroughly with product and allow to dry without wiping
For children under 6, use only under adult supervision
Not recommended for infants.
Information For Patients
Other information
Do not store above 105 degrees F
May discolor some fabrics
Harmful to wood finishes and plastics.
Inactive Ingredient
Inactive ingredients
Ingredients/ingredients: water (aqua), glycerin, trethanolamine, carbomer, fragrance (parfum), PEG-40, hydrogenated castor oil, DMCM Hydantoin, hydrogenated jojoba oil, FD and C blue No1, FD and C yellow No 5, FD and C red40
Other
Formulated exclusively and distributed by:Enchante Accessories, Inc.New York, NY 10016Not Tested On Animals. For adult use only.Designed in the USAMade in China3.1 fl oz/90 ml
Package Label.Principal Display Panel
Sugar Cookies
scented
Antibacterial
Hand Sanitizer
3.1 fl. oz. / 90ml
Handsanitizerlabel (Sugarcookies)
Handsanitizerdrugpanel (Drugfacts2)
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