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| Product NDC Code | 84338-001 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Pain relieving cream |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | CREAM | ||||||||||
| Application Number | M017 | ||||||||||
| Labeler Name | PAIN WIZARD LIMITED LIABILITY COMPANY | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Camphor 3% Menthol 3%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a physician wash hands after use with cool water adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a physician wash hands after use with cool water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Ananas Sativus (Pineapple) Fruit Extract, Arnica Montana Flower Extract, Benzoic Acid, Boswellia Carterii Resin Extract, Camellia Sinensis Flower Extract, Capsicum Annuum Extract, Carbomer, Decyl Glucoside, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Methyl Sulfonyl Methane, Phenoxyethanol, Propylene Glycol, Rosa Centifolia Flower Extract, Salix Alba (Willow) Bark Extract, Sodium Hydroxide, Sorbic Acid, Vitis Vinifera (Grape) Seed Extract, Water, Zingiber Officinale (Ginger) Root Extract
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis sprains bruises strains
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relieving Cream Camphor and Menthol SODIUM HYDROXIDE ANANAS SATIVUS (PINEAPPLE) FRUIT ROSA CENTIFOLIA FLOWER BENZOIC ACID PROPYLENE GLYCOL DECYL GLUCOSIDE DIMETHYL SULFONE VITIS VINIFERA SEED SORBIC ACID CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) SALIX ALBA BARK FRANKINCENSE GINGER ALOE VERA LEAF PHENOXYETHANOL HAMAMELIS VIRGINIANA TOP WATER GLYCERIN WATER CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ARNICA MONTANA FLOWER MENTHOL MENTHOL CAPSICUM CAMELLIA SINENSIS FLOWER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Pain Wizard PAIN RELIEVING CREAM Camphor 3% & Menthol 3% Relief for Muscular & Arthritic Pain with Arnica & MSM 16 FL OZ / 473.17 ML PW 16oz new label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a physician wash hands after use with cool water
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 20-25°C (68-77°F) store in a cool, dry place away from direct sunlight
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product use only as directed avoid contact with the eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) to the area of use
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only When using this product use only as directed avoid contact with the eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) to the area of use Stop use and ask a doctor if condition worsens, or 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API