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| Product NDC Code | 58503-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Ice cold topical analgesic gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 866128 | ||||
| Application Number | part348 | ||||
| Labeler Name | China Ningbo Shangge Cosmetic Technology Corp. | ||||
| 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 Ingredient Purpose Menthol 1.25%...........................Topical Analgesic
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 see important warnings under "When using this product" adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily. children under 2 years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, 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.Other information store at 20oC to 25oC (68o to 77oF)
Purpose
Information about the drug product’s indications for use.Uses forthe temporary relief of minor aches and pains of muscles and joints.
Spl product data elements
Usually a list of ingredients in a drug product.Ice Cold Topical Analgesic Gel Menthol MENTHOL MENTHOL WATER CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) ALCOHOL ISOPROPYL ALCOHOL CAMPHOR (NATURAL) FD&C BLUE NO. 1 METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE SODIUM HYDROXIDE
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.label image
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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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. Avoid contact with eyes. Ask a doctor before use if you have cough associated with smoking excessive phlegm asthma emphysema persistent or chronic cough When using this product do not heat microwafe add to hot water or any container where healing water may cause splattering and result in burns use in eyes or directly on mucous membranes take by mouth or place in nostrils apply to wounds or damaged skin bandage skin Consult a doctor and discontinue use if condition worsesn, persists for more than 1 week or tends to recur.
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