Label: PAINMD MAX- capsaicin, histamine dihydrocholoride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55992-404-11 - Packager: OMG Medical Group, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 21, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
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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
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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
- Other information
- KEEP OUT OF REACH OF CHILDREN
- Purpose
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAINMD MAX
capsaicin, histamine dihydrocholoride creamProduct 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)
