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Product NDC Code | 72197-007 | ||||||
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Drug Name | Pharmacys prescription vapor rub |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | GEL | ||||||
Application Number | part341 | ||||||
Labeler Name | American Consumer Products Corp | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Active Ingredients Camphor 4.7% Menthol 1.0% Eucalyptus Oil 1.0%
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.Dosage & Administration Directions: Adults and children 2 years of age and older, rub a thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds, or rub on sore aching aching muscles. If desired, loosely cover with a soft dry cloth, but keep clothing loose. Repeat up to three times daily, especially at bedtime. Children under 2 years of age, consult your physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive Ingredients: Petrolatum, Cedar Leaf Oil, Nutmeg Oil, 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.Indications & Usage USE: To temporarily relieve nasal congestion, chest congestion and cough due to the common cold. Temporarily relieves minor aches and pains.
Purpose
Information about the drug product’s indications for use.Purpose Purpose Decongestant Decongestant Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Pharmacys Prescription Vapor Rub MENTHOL MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM EUCALYPTUS OIL EUCALYPTUS OIL PETROLATUM NUTMEG OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) CEDAR LEAF OIL TURPENTINE OIL THYMOL
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.Pharmacy's Prescription 4 OZ Vapor Rub Pharmacys Prescription Vapor Rub
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Consult a Physician Before Use Consult a physician before use. If you have asthma, emphysema, persistent or chronic cough associated with smoking or excessive mucus. If muscle aches persist for more than 7 days or comes back, or cough lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache.
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 Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center right away.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.If Pregnant or Breast Feeding If pregnant or breast feeding, consult a physician before use. Do not use near open flame, in a microwave oven or in a container in which water is being heated except when adding to cold water in a hot steam vaporizer.
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.Warning Warning: For external use only. Not for internal use. Avoid contact with eyes. Do not put in mouth, nostrils, or on wounds or damaged skin.
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