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Product NDC Code | 69375-006 | ||||
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Drug Name | Capsaicin hp arthritis pain relief |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M017 | ||||
Labeler Name | Nationwide Pharmaceutical LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Capsaicin 0.1%
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 over 18 years: apply to affected area massage into painful area until thoroughly absorbed repeat if necessary, but no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER children 18 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, isopropyl myristate, cetyl alcohol, PEG-40 stearate, glyceryl stearate, sorbitol, petroleum jelly, water
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 minor pain associated with: arthritis simple backache muscle strains sprains bruises
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.Capsaicin HP Arthritis Pain Relief capsaicin CAPSAICIN CAPSAICIN Benzyl Alcohol Isopropyl Myristate Cetyl Alcohol PEG-40 MONOSTEARATE Glyceryl Monostearate Sorbitol PETROLATUM Water
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.PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton Nationwide Pharmaceutical • Deep Penetrating • Odor Free NDC# 69375-0006-60 CAPSAICIN HP High Potency CAPSAICIN 0.1% / TOPICAL ANALGESIC CREAM ARTHRITIS PAIN RELIEF Compare to the active ingredient in Capzasin HP ® †† NET WT 2.0 oz (56.6 g) PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton
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
Manufactured for and Distributed by: Nationwide Pharmaceutical San Antonio, TX, 78216
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 Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions: or comments 1-800-697-3329
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 redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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 If you are a first time user and think your skin might be sensitive to Capsaicin, test it on a small area first rare cases of serious burns have been reported with products of this type do not bandage tightly or apply local heat (such as heating pads) to the area of use avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skln a transient burning sensation may occur upon application but generally disappears in several days if severe burning occurs, discontinue use immediately and read inside carton for important Information do not expose the area treated with product to heat or direct sunlight do not use al the same time as other topical analgesics use only as directed. Read and follow all directions and warnings on this carton do not use if you are allergic to capsaicin or chili peppers
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.store at 15°-25°C (59°-77°F)
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 If you are a first time user and think your skin might be sensitive to Capsaicin, test it on a small area first rare cases of serious burns have been reported with products of this type do not bandage tightly or apply local heat (such as heating pads) to the area of use avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skln a transient burning sensation may occur upon application but generally disappears in several days if severe burning occurs, discontinue use immediately and read inside carton for important Information do not expose the area treated with product to heat or direct sunlight do not use al the same time as other topical analgesics use only as directed. Read and follow all directions and warnings on this carton do not use if you are allergic to capsaicin or chili peppers Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.
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