Active Ingredient
Arnica Montana (3X H.P.U.S.)
Real Time Pain Relief Hemp Oil Plus
FDA Label NDC 58133-101
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 Real Time Pain Relief Hemp Oil Plus (NDC 58133-101). 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
Bruising, Stiffness, Pain
*The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Uses:
Temporarily relieves symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.
Warnings:
for external use only
When Using This Product:
- Avoid contact with eyes.
- 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.
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.
Other Ingredients:
Aloe Barbadensis Leaf Juice, Purified Water, Methylsulfonylmethane, Sorbitol, Cetearyl Alcohol, Cetyl Alcohol, SD Alcohol 40, Tocopheryl Acetate, Emu Oil, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Caprylyl Glycol, Carbomer, Triethanolamine, Fragrance, Glycerin, Curcuma Longa (Tumeric) Root Extract, Wasabi Japonica Root Extract, Salix Alba (Willow) Bark Extract, Mentha Piperita (Peppermint) Leaf Oil, Industrial Hemp Seed Oil, Menthol, Extracts of: (Calendula officinalis (Marigold), Anthemis nobilis (Roman Chamomile), Tilia cordata (Lime Tree), Centaurea cyanus (Cornflower), Chamomilla recutita (Matricaria Chamomilla), Hypericum perforatum (St. John’s Wort)), Coriandrum Sativum (Coriander) Fruit Oil.
* Please review the disclaimer below.
