DR. MIKES PONOS PAIN RELIEF CREAM ROLL-ON- histamine dihydrochloride, menthol cream

DR. MIKES Ponos Pain Relief Cream Roll-On by

Drug Labeling and Warnings

DR. MIKES Ponos Pain Relief Cream Roll-On 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

Drug Facts

Active Ingredients

Histamine DHCl 0.03 %

Menthol 3%

Purpose

Topical Analgesic

Uses:

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

Warnings:

For external use only

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

When using this product

• Avoid contact with the eyes

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use

Directions:

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: consult a doctor.

Other Information:

• Protect the product in this container from excessive heat and direct sun.

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, Cetearyl Olivate, Cetyl Alcohol, Cetyl Myristoleate, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Dimethyl Sulfone (DMSO), Gluconolactone, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Olea Europaea (Olive) Oil, Pistacia Lentiscus (Mastic) Oil, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropyl sulfonate, Sorbitan Olivate, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol, Zingiber Officinalis (Ginger) Oil.

Questions or Comments?

Go to www.drmikesvitamins.com

Package Labeling:

INGREDIENTS AND APPEARANCE

DR. MIKES PONOS PAIN RELIEF CREAM ROLL-ON 
histamine dihydrochloride, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71067-359
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.3 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SHEA BUTTER (UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CUCUMBER (UNII: YY7C30VXJT)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB)
PEPPERMINT OIL (UNII: AV092KU4JH)
OLIVE OIL (UNII: 6UYK2W1W1E)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71067-359-00	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/29/2022

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