Active Ingredients
Petrolatum 62% ......................................................... Skin Protectant
Menthol 0.6% .............................................................External Analgesic
Lornamead
FDA Label NDC 62721-8114
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lornamead for the product Lornamead (NDC 62721-8114). 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 ingredients, uses, warnings, otc - keep out of reach of children, directions, dosage & administration, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- For the temporary relief of pain & itching associated with cold sores and fever blisters
- Temporarily protects and helps relieve chapped or cracked lips
Warnings
For External Use Only. When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - 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.
Directions
Adults and children 12 years of age and older: Apply directly to cold sore or fever blister 1 to 3 times daily
Children under 2 years of age: Consult a doctor
Dosage & Administration
Apply directly to cold sore or fever blister 1 to 3 times daily Children under 2 years of age: ask a doctor
Other Information
Store between 15 - 30C (59-86F)
Inactive Ingredients
Beeswax, Polyisobutene, Hydrogenatede Polyisobutene, Ethylene/Propylene/Styrene Copolymer, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetracaprylate/Tetracaprate, Eucalyptus Globulus Leaf Extract, Melaleuca Alternifolia (Tea Tree) Extract, Ceretified Organic Butyrospermum Parkii (Shea Butter) Fruit, Aloe Barbadensis Leaf Extract, Lysine, Dimethicone, Allantoin, Tocopheryl Acetate (Vitamin E Acetate), Bisabolol, Chamomilla Recutita (Matricaria) Extract, Lavandula Angustifolia (Lavender) Extract, Mentha Piperita (Peppermint) Oil, Camphor, Zinc Lactate, Ascorbyl Palmitate, Propolis Extract, Helianthus Annuus (Sunflower) Seed Extract, Propylparaben, Titanium Dioxide
Package Label.Principal Display Panel
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Carton Label (Mm1)
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Tube Label (Mm2)
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