Active Ingredient
HISTAMINE DIHYDROCHLORIDE 0.03%
Arthritis Pain Relief
FDA Label NDC 83041-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Painx Llc for the product Arthritis Pain Relief (NDC 83041-101). 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 ingredient, purpose, uses, warnings, directions, pregnancy, otc - keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
TOPICAL ANALGESIC
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and 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 using and ask doctor if
- Rash appears.
- Condition worsens, if symptoms persists for more than 7 days, or if symptoms clear up and occur again within a few days.
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.
Pregnancy
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 CENTRE RIGHT AWAY.
Other Information
- Store between 40°F and 86°F (4°C and 30°C)
- Tamper Evident Feature: do not use if seal under cap is torn, broken or missing.
Inactive Ingredients
Water, Cetearyl Alcohol, Dimethicone, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Methylsulfonylmethane, Glyceryl Stearate, PEG-100 Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Emu Oil, Stearic
Acid, Tocopheryl (Vitamin E) Acetate, Glucosamine Hydrochloride, Phenoxyethanol, Menthol, Carbomer, Curcuma Longa (Turmeric) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Triethanolamine, Ethyhexylglycerin, Disodium EDTA.
* Please review the disclaimer below.
