Prosoria Anti-itch Moisturizer Lotion
FDA Label NDC 71573-120

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvothera, Inc. for the product Prosoria Anti-itch Moisturizer (NDC 71573-120). 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 other, active ingredient, purpose, use, warnings, otc - when using, stop use and consult a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (90 mL Bottle Label)

Principal Display Panel (90 mL Bottle Label)

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