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| Product NDC Code | 70722-229 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Vital vapor |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OINTMENT | ||||||||
| RxCUI drug identifier | 1812104, 1812109 |
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| Application Number | part348 | ||||||||
| Labeler Name | Little Moon Essentials | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts
Active Ingredients Camphor 0.6% Menthol 5.2%
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.Purpose Topical Analgesic
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Organic sesame oil (sesamum indicum) organic olive oil (olea europaea) organic ginger powder (zingiber officinale) organic castor oil (ricinus communis) beeswax (cera alba) eucaliptus staigeriana tea tree oil (melaleuca alternifolia) wintergreen oil (gaultheria procumbens) eucalyptus globulus oil lemongrass oil (cymbopogon citratus) lavender oil (lavandula angustifolia) nutmeg oil (myristica fragrans) ravensara oil (ravensara aromatic) sage oil (salvia officinalis)
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.Directions Adults and children over 12 years: Apply a thin layer to affected area Massage into painful area until thoroughly absorbed into skin Repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications AFTER APPLYING, WASH HANDS WITH SOAP AND WATER Children 12 years or younger: ask a doctor
Purpose
Information about the drug product’s indications for use.Uses Temporarily relieves minor pain associated with simple backache muscle strains sprains bruises
Spl product data elements
Usually a list of ingredients in a drug product.Vital Vapor Camphor, Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM WEST INDIAN LEMONGRASS OIL NUTMEG OIL SAGE OIL TEA TREE OIL METHYL SALICYLATE EUCALYPTUS OIL LAVENDER OIL CRYPTOCARYA AGATHOPHYLLA LEAF OIL OLIVE OIL GINGER CASTOR OIL YELLOW WAX EUCALYPTUS GLOBULUS LEAF CAMPHOR (NATURAL) CAMPHOR (NATURAL) SESAME OIL
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.Principle Display Panel 14g container 0.5 oz Vital Vapor Bottom 0.5 Vital Vapor Front..
Instructions for use
Information about safe handling and use of the drug product.Other information Store at 68-77ºF (20-25ºC) Protect from excessive moisture
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
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 condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury such as pain, swelling, or blistering where the product was applied
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.Warning For exteral use only When using this product use only as directed. Read and follow all directions and warnings on this label rare cases of serious burns have been reported with products of this type do not bandage tightly or apply local heat (such as heating pads) or medicated patches to teh area of use avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin a trasient burning sensation may occur upon application but generally disappears in several days
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