Active Ingredients
Capsaicin 0.0375% USP
Histamine Dihydrocholirde 0.035% USP
Painmd Max
FDA Label NDC 55992-404
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Omg Medical Group, Llc for the product Painmd Max (NDC 55992-404). 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, warnings, otc - pregnancy or breast feeding, inactive ingredients, directions, other information, otc - keep out of reach of children, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
For external use only
do not ingest
use only as directed
do not bandage tightly or use external heat or a heating pad
avoid contact with eyes, mucus membranes, vagina, penis, scrotum and anus. If eye contact occurs, rinse thoroughly with water
do not use on open wounds or damaged skin
do not use if you are allergic to ingredients in this product
stop and ask doctor if: condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, irritation develops, redness is present
if swallowed, get medical help or contact a poison control center right away
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding as a health professional before use
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cetyl Myristoleate, Cucumis Sativus
(Cucumber) Extract, Ethylhexylglycerin,Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paragauyensis (Yerba Mate) Extract, Isopropyl Myristate, Methylsulfonylmethane (MSM), PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine
Directions
Adults and children over 12 years: apply a thin leayer to the pain site and massage gently until thoroughly absorbed into the skin, repeat as necessary but not more than 4 times daily.
Children 12 years or younger: ask a doctor
Wash hands immediatly after use.
Other Information
store at controlled room temperature between 15 degrees C and 30 degrees C (59F-86F) with cap closed tight
do not use if tamper resistant seal on jar is torn, broken or missing
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Purpose
Topical Analgesic
Indications & Usage
Pain relief
* Please review the disclaimer below.
