dr. mike's ponos pain relief cream roll-on

dr. mike's ponos pain relief cream roll-on
SPL v2
SPL
SPL Set ID fcc45464-f1fe-4244-95a7-9b4288b0ce45
Route
topical
Published
Effective Date 2022-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
histamine (0.3 mg) menthol (30 mg)
Inactive Ingredients
aloe vera leaf water yellow wax indian frankincense shea butter cetostearyl alcohol cetearyl olivate cetyl alcohol cetyl myristoleate chamomile citric acid monohydrate cucumber dimethyl sulfone gluconolactone glycerin glyceryl monostearate glycyrrhiza glabra helianthus annuus flowering top hypericum perforatum whole peppermint oil olive oil pistacia lentiscus resin sodium benzoate sorbitan olivate stearic acid xanthan gum corn ginger

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-08-29

Purpose

Topical Analgesic

Description

Histamine DHCl 0.03 % Menthol 3%


Medication Information

Purpose

Topical Analgesic

Description

Histamine DHCl 0.03 % Menthol 3%

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

Drug Facts

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.
Package Labeling:

Active Ingredients

Histamine DHCl 0.03 %

Menthol 3%

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

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.

If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

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


Structured Label Content

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

Drug Facts

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.
Package Labeling:

Active Ingredients

Histamine DHCl 0.03 %

Menthol 3%

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? (Questions or Comments?)

Go to www.drmikesvitamins.com

When Using This Product (When using this product)
  • Avoid contact with the eyes
Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

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


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