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| Product NDC Code | 83520-131 | ||||
|---|---|---|---|---|---|
| Drug Name | Dermachange cold therapy |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 311502 | ||||
| Application Number | M017 | ||||
| Labeler Name | Private Label Beauty and Wellness | ||||
| 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.Menthol 2%
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.• adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. • Children under 12 years old, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Ammonium hydroxide, blue 1, carbomer, copper PCA, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, 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.For the temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Dermachange Cold Therapy Menthol AMMONIA FD&C BLUE NO. 1 WATER MENTHOL MENTHOL CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) COPPER PIDOLATE PROPYLENE GLYCOL MAGNESIUM SULFATE, UNSPECIFIED FORM ISOPROPYL ALCOHOL THYMOL 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
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.If product is swallowed, get medical help or contact a Poison Control Center right away.
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.For external use only. Do not use with other topical pain relievers, with heating pad or heating devices. When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly. Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days.
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