Arthritis Pain Relief Cream
FDA Label NDC 61577-8120

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics Inc. for the product Arthritis Pain Relief Cream (NDC 61577-8120). 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, keep out of reach of children, purpose, uses, warnings, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Histamine Dihydrochloride 0.025%

Keep Out Of Reach Of Children

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

Purpose

PURPOSE

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis

Warnings

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

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

Inactive Ingredients

Aqua (Purified Water), Butylene Glycol, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Methylsulfonylmethane (MSM), Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Chondroitin Sulfate, Glucosamine Sulfate

Questions Or Comments?

Call 1-888-600-4642

Label

Label (2ozarthlabel)

Label (2ozarthlabel)

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