Active Ingredient
Arnica Montana (2X H.P.U.S.)
*The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Homeopathic Lip Balm
FDA Label NDC 58133-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Homeopathic Lip Balm (NDC 58133-111). 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, uses, warnings, when using this product, stop use and ask a doctor if:, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain
Uses
Temporarily relieves symptoms of pain and inflammation.
Warnings
For external use only.
- If swallowed, get medical help or contact a Poison Control Center Immediately.
- Test for allergy by rubbing small amount on skin first.
- Do not use if allergic to or hypersensitive to any ingredient.
- If condition worsens or does not improve consult a doctor.
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
- Redness is present
- Irritation develops
Otc - Keep Out Of Reach Of Children
Keep all medicines out of reach of children.
Directions
Apply to affected area 2 times daily or as needed.
Inactive Ingredients
Petrolatum, Synthetic Beeswax, Isopropyl Palmitate, Menthol, Lanolin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Natural Flavor, Lavandula Angustifolia (Lavender) Oil, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Butyrospermum Parkii (Shea) Butter, Mentha Piperita (Peppermint) Leaf Oil, Isopropyl Myristate, Also Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) See Oil, Camphor, Butylene Glycol, Stevia Rebaudiana Leaf/Stem Extract.
* Please review the disclaimer below.
