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Product NDC Code | 73635-5801 | ||||
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Drug Name | Germa vapozol chest-rub |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 2667937 | ||||
Application Number | M017 | ||||
Labeler Name | Germa Products, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 1.8%
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 Directions • see important warnings under “When using this product” • adults and children 2 years and over; • 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 • not intended for use by persons under the age of 18.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients White petrolatum, camphor, eucalyptus oil, nutmeg 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.When using this product, do not • heat n microwave • add to hot water or any container where heating water may cause splattering and result in burns.
Purpose
Information about the drug product’s indications for use.Purpose Cough Suppressant & Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Germa Vapozol Chest-Rub Menthol WHITE PETROLATUM NUTMEG OIL MENTHOL MENTHOL, UNSPECIFIED FORM EUCALYPTUS OIL CAMPHOR (SYNTHETIC)
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.Vapozol
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.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. • pregnant or breastfeeding. Ask a doctor before use if you have n cough that occurs with too much phlegm (mucus) n persistent or chronic cough such as occurs with smoking, asthma or emphysema.
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.Warnings Keep out of reach of children. • In case of accidental ingestion, 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 controlled room temperature 15-30ºC (59-86ºF)
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.Uses Uses • on chest and throat, temporarily relieves cough due to the common cold. • on muscles and joints, temporarily relieves minor aches and pains.
Pregnancy or breast feeding
Pregnancy or Breast feedingStop use and ask a doctor if pregnant or breastfeeding.
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 the eyes. Do not use • by mouth • with tight bandages • in nostrils • on wounds or damaged skin • Do not use if safety seal is torn, broken or missing.
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