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| Product NDC Code | 57337-051 | ||||
|---|---|---|---|---|---|
| Drug Name | Xtracare vaporizing chest rub |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1487908 | ||||
| Application Number | M012 | ||||
| Labeler Name | Rejoice International | ||||
| 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 Purpose Camphor 4.8% ..................................... Cough Suppressant Menthol 1.0% ............................................ 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 and children 2 years old and older: rub a thick layer on chest & throat or rub on sore aching muscles cover with a warm, dry cloth if desired keep clothing loose about throat chest to help vapors reach the nose/mouth repeat up to three times per 24 hours or as directed by doctor children under 2 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil
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.XtraCare® Vaporizing Chest Rub Cough Suppressant Net Wt 4 Oz (113 g)
Purpose
Information about the drug product’s indications for use.Uses on chest and throat, temporarily relieves cough as may occur with common cold and minor bronchial irritation. for the temporary relief of pain associated with minor skin irritation.
Spl product data elements
Usually a list of ingredients in a drug product.XtraCare Vaporizing Chest Rub Camphor, Menthol CEDAR LEAF OIL NUTMEG OIL PETROLATUM THYMOL TURPENTINE OIL CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL MENTHOL
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. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: store at room temperature Questions/Comments? 1-855-345-5575 DISTRIBUTED BY: REJOICE INTERNATIONAL INC NORTHVILLE, MI 48168 USA MADE IN CHINA
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. Do not use by mouth in nostrils on wounds or damaged skin with tight bandages Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma or emphysema When using this product, do not heat microwave add to hot water or any container where heating water. May cause splattering and result in burns. Stop use and ask a doctor if muscle aches and pains persist more than 7 days or come back cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use.
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