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| Product NDC Code | 81470-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Shield and heal medicated lip balm |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | STICK | ||||||
| Application Number | part348 | ||||||
| Labeler Name | Shield and Heal Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. children under 2 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Helianthus Annuus (Sunflower) Seed Oil, Moringa Oil/Hydrogenated Moringa Oil Esters, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera Cera, Ricinus Communis (Castor) Seed Oil, Lanolin, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter Unsaponifiables, Camphor, Avena Sativa (Oat) Kernel Flour, Butyrospermum Parkii (Shea Butter), Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus Leaf Oil, Garcinia Indica Seed Butter, Glyceryl Laurate, Hippophae Rhamnoides (Sea Buckthorn) Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Pongamia Glabra Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Propolis Extract, Water, Achillea Millefolium Flower 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.Use 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 External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Shield and Heal Medicated Lip Balm Menthol GLYCERYL LAURATE CASTOR OIL ORANGE OIL JOJOBA OIL ACHILLEA MILLEFOLIUM WHOLE LAVENDER OIL WATER GARCINIA INDICA SEED BUTTER PROPOLIS WAX SUNFLOWER OIL CANDELILLA WAX .ALPHA.-TOCOPHEROL ACETATE SYNTHETIC BEESWAX CARNAUBA WAX BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES TOCOPHEROL COCONUT OIL HIPPOPHAE RHAMNOIDES FRUIT OIL GLYCERIN CAMPHOR (SYNTHETIC) KARUM SEED OIL OATMEAL LANOLIN SHEA BUTTER EUCALYPTUS OIL MENTHOL MENTHOL
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.Product Packaging 1 pack
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
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.
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 room temperature and avoid excessive heat.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call toll free 888-933-3253 or learn more at www.shieldandheal.com
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.
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. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. When using this product avoid contact with eyes. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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