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Product NDC Code | 72812-155 | ||||
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Drug Name | Medicated herbal lip balm |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | STICK | ||||
RxCUI drug identifier | 418610 | ||||
Application Number | M017 | ||||
Labeler Name | Earth Mama Angel Baby LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Menthol 1%
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 adults & children 2 years of age and older: apply a small amount of product to affected area not more than 3 to 4 times daily wash hands before and after applying balm do not share product with anyone else children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients *Beeswax, *Calendula Flower Extract, *Chamomile Extract, *Cocoa Butter, *Coconut Oil, *Echinacea Root Extract, *Eucalyptus Oil, *Licorice Root Extract, *Lemon Balm Leaf Extract, *Peppermint Oil, *Rosemary Extract, *St John's Wort Extract, *Sunflower Oil, *Tea Tree Oil, Mixed Tocopherols. *Organic
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.Uses For the temporary relief of pain and itching associated with fever blisters and cold sores.
Purpose
Information about the drug product’s indications for use.Purpose Fever blister / cold sore treatment
Spl product data elements
Usually a list of ingredients in a drug product.Medicated Herbal Lip Balm Menthol SUNFLOWER OIL TEA TREE OIL CHAMOMILE FLOWER OIL COCOA BUTTER ROSEMARY OIL PEPPERMINT OIL COCONUT OIL TOCOPHEROL CALENDULA OFFICINALIS FLOWER YELLOW WAX MELISSA OFFICINALIS LEAF OIL EUCALYPTUS OIL ECHINACEA ANGUSTIFOLIA ROOT ST. JOHN'S WORT LICORICE MENTHOL MENTHOL Refreshing Menthol Mint
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.Carton Artwork Earth Mama Medicated Herbal Lip Balm 0.15 oz (4.25 g) Carton Artwork
Label Artwork Earth Mama Medicated Herbal Lip Balm 0.15 oz (4.25 g) Tube Label Artwork
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Carton Text Herbal Fever Blister & Cold Sore Treatment earth mama ORGANICS MEDICATED HERBAL Lip Balm Refreshing Menthol Mint Net Wt 0.15 Oz (4.25 g) 100% PLASTIC FREE Haven't got time for the pain? Try this thoughtfully formulated medicated lip balm for fever blisters and cold sores. FOR EVERYONE AND THEIR MOTHER Distributed by Earth Mama Angel Baby LLC 9866 SE Empire Ct., Clackamas, OR 97015 USA EarthMama.com Certified Organic by Oregon Tilth B10-521-00 With Organic echinacea root, licorice root, chamomile and more.
Label Text earth mama ORGANICS MEDICATED HERBAL Lip Balm HERBAL FEVER BLISTER & COLD SORE TREATMENT Net Wt 0.15 Oz (4.25 g) 100% PLASTIC FREE Distributed by Earth Mama Angel Baby LLC 9866 SE Empire Ct., Clackamas, OR 97015 USA EarthMama.com Certified Organic by Oregon Tilth L10-521-00 Refreshing Menthol Mint
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. (1-800-222-1222)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call 503-607-0607 Monday-Friday 7:30 a.m to 4 p.m. pacific
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 if condition worsens symptoms last 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
Storage and handling
Information about safe storage and handling of the drug product.Other information protect from excessive heat and direct sunlight
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 When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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