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PainMD Max

Dosage form: cream
Ingredients: CAPSAICIN 3.75mg in 1mg, HISTAMINE DIHYDROCHLORIDE 3.5mg in 1mg
Labeler: OMG Medical Group, LLC
NDC Code: 55992-404

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

PainMD Max

Active Ingredients

Capsaicin 0.0375% USP

Histamine Dihydrocholirde 0.035% USP

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

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

Keep out of reach of children

Purpose

Topical Analgesic

Pain relief

PAINMD MAX 
capsaicin, histamine dihydrocholoride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55992-404
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN3.75 mg  in 1 mg
HISTAMINE DIHYDROCHLORIDE (HISTAMINE) HISTAMINE DIHYDROCHLORIDE3.5 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER 
ALOE VERA WHOLE 
water 
ARNICA MONTANA FLOWER 
BOSWELLIA SACRA WHOLE 
MEDIUM-CHAIN TRIGLYCERIDES 
CETYL ALCOHOL 
CETYL MYRISTOLEATE 
CUCUMIS SATIVUS WHOLE 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
GLYCYRRHIZA GLABRA 
ILEX PARAGUARIENSIS WHOLE 
ISOPROPYL MYRISTATE 
DIMETHYL SULFONE 
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES 
PHENOXYETHANOL 
SODIUM LAURYL SULFATE 
TRIETHANOLAMINE BENZOATE 
Packaging
#Item CodePackage Description
1NDC:55992-404-113.75 mg in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/22/2014
Labeler - OMG Medical Group, LLC (038837214)
Establishment
NameAddressID/FEIOperations
OMG Medical Group, LLC038837214repack(55992-404)
Establishment
NameAddressID/FEIOperations
Pure Source969241041manufacture(55992-404)

 
OMG Medical Group, LLC

Medically reviewed on Jul 23, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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