Pain Relieving Arthritis
FDA Label NDC 76168-108

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma Llc for the product Pain Relieving Arthritis (NDC 76168-108). 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, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Active Ingredient

Histamine dihydrochloride ...... 0.025%

Purpose

External Analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains & bruises.

Warnings

  • For external use only.
  • Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.

When Using This Product

  • avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
  • do not bandage tightly or use a heating pad.

Stop Use And Ask A Doctor If

  • rash appears.
  • condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For Use by Adults and Children over 12 years.
  • Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.
  • Children 12 years or younger consult a physician.

Other Information

  • Store between 40°F and 86°F ( 4°C and 30C).
  • Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.

Inactive Ingredients

butylated hydroxyl toluene, cetostearyl alcohol , cetomacrogol 1000, cetyl alcohol, disodium EDTA, disodium hydrogen phosphate, light liquid paraffin, propylene glycol, sorbic acid, transquitol P, white petroleum jelly

Questions Or Comments? Call 1855-314-1850

Distributed by: Velocity Pharma LLC 
Farmingdale, NY, 11735

Package Label.Principal Display Panel

Pain Relieving Arthritis Cream

Net Wt. 4 oz (119g)

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