ROPANA Pain Relief Cream .4 mg/mL

HISTAMINE DIHYDROCHLORIDE · CREAM · FUSION PAIN SOLUTIONS LLC

No Recall History

Plain English

ROPANA Pain Relief Cream is a cream containing histamine dihydrochloride at .4 mg/mL, taken topical. Manufactured by FUSION PAIN SOLUTIONS LLC.

Key Facts

Brand Name: ROPANA Pain Relief Cream
Generic Name: HISTAMINE DIHYDROCHLORIDE
NDC Code (Product): 83613-411
Manufacturer: FUSION PAIN SOLUTIONS LLC
Strength: .4 mg/mL
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: M017
Marketing Start: 08/21/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

colon cancer metastatic3 reports

diarrhoea3 reports

back pain2 reports

dizziness2 reports

accidental exposure to product1 reports

allergy test positive1 reports

ankylosing spondylitis1 reports

anxiety1 reports

blood pressure increased1 reports

chronic fatigue syndrome1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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.

Warnings

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

Frequently Asked Questions

What is ROPANA Pain Relief Cream used for?

ROPANA Pain Relief Cream contains HISTAMINE DIHYDROCHLORIDE. It is a cream taken topical. Consult your doctor for specific uses.

Is ROPANA Pain Relief Cream a controlled substance?

ROPANA Pain Relief Cream is not classified as a controlled substance by the DEA.

What is the generic name for ROPANA Pain Relief Cream?

The generic name for ROPANA Pain Relief Cream is HISTAMINE DIHYDROCHLORIDE. There are 12 other brand versions of HISTAMINE DIHYDROCHLORIDE.

What is the NDC code for ROPANA Pain Relief Cream .4 mg/mL?

The NDC (National Drug Code) for ROPANA Pain Relief Cream .4 mg/mL is 83613-411, listed by FUSION PAIN SOLUTIONS LLC.

Product NDC

83613-411

Package NDC

83613-411-00

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)