PONOS NATURAL PAIN RELIEF- menthol, histamine dihydrochloride cream

PONOS NATURAL PAIN RELIEF by

Drug Labeling and Warnings

PONOS NATURAL PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Dr. Mike's Vitamins, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

 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:

INGREDIENTS AND APPEARANCE

PONOS NATURAL PAIN RELIEF 
menthol, histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71067-767
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg  in 1 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
YELLOW WAX (UNII: 2ZA36H0S2V)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SHEA BUTTER (UNII: K49155WL9Y)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71067-767-35	1 in 1 BOX	11/18/2016
1		99 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/18/2016

Labeler - Dr. Mike's Vitamins, LLC (080432373)