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Product NDC Code | 73498-022 | ||||
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Drug Name | Natures willow bug bite balm |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 2475473 | ||||
Application Number | M017 | ||||
Labeler Name | WB Ventures LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 and children over 2 years of age: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Almond Oil, Camphor, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Eucalyptus Oil, Geranium Oil, Glyceryl Stearate SE, Helichrysum Gymnocephalum Oil, Isopropyl Palmitate, Jojoba Seed Extract, Lavender Oil, Lemongrass Oil, Palmitic Acid, Phenoxyethanol, Propanediol, Sorbic Acid, Stearic Acid, Stearyl Alcohol, Sunflower Oil, Triethanolamine, Water, White Willow Bark Extract
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: - insect bites - minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Natures Willow Bug Bite Balm Menthol STEARIC ACID PELARGONIUM GRAVEOLENS FLOWER OIL GLYCERYL STEARATE SE PROPANEDIOL POLYOXYL 20 CETOSTEARYL ETHER WEST INDIAN LEMONGRASS OIL SIMMONDSIA CHINENSIS SEED ISOPROPYL PALMITATE HELICHRYSUM GYMNOCEPHALUM WHOLE EUCALYPTUS OIL CETYL ALCOHOL CETOSTEARYL ALCOHOL CAPRYLYL GLYCOL CAMPHOR (SYNTHETIC) SORBIC ACID SALIX ALBA BARK SUNFLOWER OIL STEARYL ALCOHOL PHENOXYETHANOL PALMITIC ACID LAVENDER OIL MENTHOL MENTHOL WATER TROLAMINE ALMOND 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.Packaging Label Box Image DP Tube label
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.SPL Unclassified Section Drug Facts
SPL Unclassified Section Distributed by WB Ventures LLC, Cincinnati, OH 45212 For more information or to report a serious adverse event contact 1-888-609-4556
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 swallowed, get medical help or contact a Poison Control Center right away.
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 persist for more than 7 days or clear up and occur again within a few days 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