PONOS NATURAL PAIN RELIEF- menthol, histamine dihydrochloride cream 
Dr. Mike's Vitamins, LLC

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PONOS NATURAL PAIN RELIEF CREAM

 Drug Facts

Active Ingredient

Menthol (3.00%)

Histamine DHCL (0.050%)

Purpose

Topical Analgesic

Indications

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.      

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not apply

  • to wounds or damaged skin.
  • Do not bandage tightly.

Directions

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.

Other Information

Store at room remperature.

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, aqua (Deionized Water), Arnica Montana Flower Extract, Beeswax, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cetyl Alcohol, Cetyl Myristoleate, Chamomilla Recutita (Chamomile) Extract, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Dimethyl SUlfoxide (DMSO), Gluconolactone, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort) Flower Extract, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Olea Europaea (Olive) Oil, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropylsulfonate, Stearic Acid, Zemea (Corn) Propanediol

Package Labeling:

Label

PONOS NATURAL PAIN RELIEF 
menthol, histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71067-767
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
CHAMOMILE (UNII: FGL3685T2X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CUCUMBER (UNII: YY7C30VXJT)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CORN (UNII: 0N8672707O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71067-767-351 in 1 BOX11/18/201612/11/2018
199 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/18/201612/11/2018
Labeler - Dr. Mike's Vitamins, LLC (080432373)

Revised: 10/2023
 
Dr. Mike's Vitamins, LLC