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| Product NDC Code | 63347-401 | ||||||||||
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| Drug Name | Ortho-nesic with capsaicin |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | GEL | ||||||||||
| RxCUI drug identifier | 416207, 1087242 |
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| Application Number | M012 | ||||||||||
| Labeler Name | Blaine Labs Inc. | ||||||||||
| 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 - 0.2% Menthol - 3/5%
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.When Using This Product Avoid contact with the eyes or mucous membranes. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, SDA Alcohol 40-B, Carbomer, Isopropyl Alcohol, Ilex Paraguariensis Leaf Extract, Camelia Sinensis (Green Tea) Leaf Powder, FD and C Blue #1, FD and C Yellow #5, Triethanolamine
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 For temporary relief from minor aches and pains of sore muscles and joints associated with arthritis pain, backache, strains and sprains Directions: Apply to the affected areas not more than 3 to 4 times daily. Rinse hands with cool water.
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.Ortho-Nesic With Capsaicin Menthol MENTHOL MENTHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) WATER ALCOHOL CARBOMER 934 ISOPROPYL ALCOHOL ILEX PARAGUARIENSIS LEAF GREEN TEA LEAF FD&C BLUE NO. 1 FD&C YELLOW NO. 5 TROLAMINE CAPSAICIN
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.Ortho-Nesic Label Ortho-Nesic Pain Relieving Gel Penetrates Fast and Deep Relieves Sore Muscles and Joints Physician Formula Greaseless, Stainless Great for Arthritis and Sports Injuries Stops the Pain. With Capsaicin, Ilex and Green Tea. Paraben Free res8.14.20 RES blaine_o-n_gel_capsa_6oz blaine_o-n_paraben_free_1gal blaine_o-n_roll_on_capsa_3oz
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.Ask Your Physician Ask Your Physician Before use if you are pregnant, nursing or have sensitive skin Before use on children under the age of 2 years old Keep Out Of The Reach Of Children Stop Use and Contact Your Physician if conditions worsen or if symptoms persist for more than 7 days, or clear up and recur again within a few days.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store in a cool dry place with lid closed tightly. Keep away from excessive heat or open flame
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 Use only as directed. For external use only. Do not use with other sprays or ointments creams or liniments. Do not apply to irritated skin or if excessive irritation develops. Do Not bandage. Do not sue with heating pads or devices.
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