FDA Label for Prosoria Anti-itch Moisturizer
View Indications, Usage & Precautions
Prosoria Anti-itch Moisturizer Product Label
The following document was submitted to the FDA by the labeler of this product Nuvothera, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by Nuvothera, Inc.
Fort Worth, Texas 76104
Active Ingredient
Pramoxine HCL 1%
Purpose
External analgesic
Use
for the temporary relief of itching associated with minor skin irritations
Warnings
For external use only
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop Use And Consult A Doctor If
- the condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days.
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.
Directions
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: consult a doctor
Inactive Ingredients
Water, White Petrolatum, Glycerin, PEG-100 Stearate, Glyceryl Stearate SE, Stearic Acid, Copaifera Coriacea Resin Oil, Tetrahydrodiferuloylmethane, Cetyl Alcohol, Stearyl Alcohol, Phenoxyethanol, Vitamin E (Tocopheryl acetate), Xanthan Gum, Sodium Citrate, Disodium EDTA.
Questions?
Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT.
Principal Display Panel - 90 Ml Bottle Label
moisturizes
relieves itching
prosoriä
anti-itch
moisturizer
Pramoxine Hydrochloride 1%
external analgesic
3 FL OZ (90mL)
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