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| Product NDC Code | 58133-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Control menstrual cramp relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1442261 | ||||
| Application Number | part348 | ||||
| Labeler Name | Cosmetic Specialty 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 Ingredient Menthol, 3.0%
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 12 years:• apply to affected area • massage into painful area until throughly absorbed into skin • repeat as necessary, but no more than 4 time daily Children 12 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Butylene Glycol, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Chamomilla recutita (Matricaria) Flower Extract, Citrus aurantium Dulcis (Sweet Orange) Peel Oil, Cocos nucifera (Coconut) Oil, Creatine Monohydrate, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Sodium Laureth Sulfate, Stearic Acid, 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 temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps
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.Control Menstrual Cramp Relief Menthol PHENOXYETHANOL WATER CHAMOMILE ORANGE OIL, COLD PRESSED COCONUT OIL BUTYLENE GLYCOL CAPRYLYL GLYCOL CETYL ALCOHOL LAURETH-4 STEARIC ACID GLYCERYL STEARATE SE SAGE OIL MENTHOL MENTHOL CREATINE MONOHYDRATE TROLAMINE DIMETHICONE EUCALYPTUS OIL SODIUM LAURETH SULFATE CARBOMER 940
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.Package label Control
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 right away.
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 • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develeps
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 eyes or mucous membranes • do not apply to wounds or damaged skin
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
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