Active Ingredient
Menthol 1%
Shield And Heal Lip Balm
FDA Label NDC 81470-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shield And Heal Inc. for the product Shield And Heal Lip Balm (NDC 81470-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, when using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Use
for the temporary relief of pain and itching associated with fever blisters and cold sores.
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.
Directions
- children under 2 years of age: consult a doctor.
- adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
Other Information
- Store at room temperature and avoid excessive heat.
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.
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