PAINMD MAX- capsaicin, histamine dihydrocholoride cream

PainMD Max by

Drug Labeling and Warnings

PainMD Max by is a Otc medication manufactured, distributed, or labeled by OMG Medical Group, LLC, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Purpose

Topical Analgesic

INDICATIONS & USAGE

Pain relief

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAINMD MAX 
capsaicin, histamine dihydrocholoride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55992-404
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	3.75 mg  in 1 mg
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	3.5 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
water (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ILEX PARAGUARIENSIS WHOLE (UNII: QJB02841ZY)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55992-404-11	3.75 mg in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/22/2014

Labeler - OMG Medical Group, LLC (038837214)

Establishment
Name	Address	ID/FEI	Business Operations
OMG Medical Group, LLC		038837214	repack(55992-404)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		969241041	manufacture(55992-404)