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| Product NDC Code | 72683-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Ease your pain |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1148430 | ||||
| Application Number | part348 | ||||
| Labeler Name | Proximity Capital Partners LLC dba Asutra | ||||
| 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 USP 4%
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 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Purified Water, Ethyl Alcohol, Dimethyl Sulfone (MSM), Arnica Montana, Calendula Officinalis Flower Extract, Methyl Glucose Dioleate, Sodium Hydroxide, Baobab Oil, Carbomer, Citric Acid
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 of muscles and joints associated with simple backache arthritis strains bruises sprains
Purpose
Information about the drug product’s indications for use.Menthol USP 4% ........................... Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Ease Your Pain Menthol ADANSONIA DIGITATA SEED OIL MENTHOL MENTHOL ARNICA MONTANA CALENDULA OFFICINALIS FLOWER CARBOXYPOLYMETHYLENE CITRIC ACID MONOHYDRATE DIMETHYL SULFONE ALCOHOL METHYL GLUCOSE DIOLEATE SODIUM HYDROXIDE 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.001
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 accidentally ingested, 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.888-819-6472 Monday - Friday, 9am - 5pm CT Report any serious side effects to number above.
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 doctor if: Condition worsens Symptoms persist for more than 7 days, or clear up and occur again within a few days
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: Avoid contact with eyes and mucous membranes Do not apply to wounds or damaged skin Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding: Ask a health professional before using.
Storage and handling
Information about safe storage and handling of the drug product.Store in a cool, dry place. Avoid direct sunlight. Tamper-evident for your protection. Use only if safety seal is intact. Keep away from excessive heat or 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.Use only as directed. For external use only. Keep away from excessive heat or flame. When using this product: Avoid contact with eyes and mucous membranes Do not apply to wounds or damaged skin Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments Stop use and ask doctor if: Condition worsens Symptoms persist for more than 7 days, or clear up and occur again within a few days If pregnant or breastfeeding: Ask a health professional before using. Keep out of reach of children . If accidentally ingested, 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