Gellert Joint Care
FDA Label NDC 49834-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gellert Health Solutions Llc for the product Gellert Joint Care (NDC 49834-001). 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 active ingredients, purpose, indications & usage, warnings, do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Capsaicin 0.17%

Purpose

External Analgesic

Indications & Usage

Uses temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, muscle strains, sprains and bruises.

Warnings

For external use only

Do Not Use

  • on wounds or damaged skin
  • with tight bandages

When Using This Product

  • avoid contact with the eyes and mucous membranes

Stop Use And Ask A Doctor If

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • skin redness or excessive irritation of the skin develops

Otc - Pregnancy Or Breast Feeding

  • if pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

  • keep out of reach of children, if swallowed, get medical help or contact a poison control center right away.

Directions

  • Adults and children 2 years of age and older: Apply a thin layer to the affected area in the morning and evening on dry clean skin
  • Recommended use for at least two weeks consistently
  • Children under 2 years of age: consult a physician

Other Information

  • Store below 25°C (77°F)
  • This package has a tamper-evident seal. If the seal is broken, do not use

Inactive Ingredient

Inactive Ingredients Ascorbic Acid (Vitamin C), Cetyl alcohol, Distilled water, Glucosamine sulphate, Methylparaben, Methylsothiazolinone, Methylsulfonylmethane, Natural triglycerides (Omega-3), Peppermit extract, Polyethyleneglycol esters.

Questions?

Call 1 (888) 434-2235; 9am - 5pm EST

Or visit: www.GellertHealth.com

Package Label.Principal Display Panel

Principal Display Panel - Gellert Joint Care - 45g Carton

Principal Display Panel (Gellert Joint Care)

Principal Display Panel (Gellert Joint Care)

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