Ropana Pain Relief Cream
FDA Label NDC 83613-411

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fusion Pain Solutions Llc for the product Ropana Pain Relief Cream (NDC 83613-411). 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 drug facts, active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Histamine DHCl 0.04%

Purpose

Topical Analgesic

Uses:

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

Warnings:

For external use only

Do Not Use

  • on damaged or broken skin.

When Using This Product

  • Avoid contact with the eyes.

Stop Use And Ask A Doctor If

  • Rash or irritation develops and lasts.
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions:

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Chldren under 2 years of age: consult a doctor.

Other Information:

Protct the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cinnamomum Cassia Oil, Curcuma Longa (Turmeric) Extract, Cyclopentasiloxane, Dodecane, Ethylhexylglycerin, Ethyl Vanillin, Glyceryl Stearate, Glycyrrhiza Glaba (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Stearic Acid, Triethanolamine, Xanthan Gum.

Package Labeling:

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