Otc-Active Ingredients
Menthol 10%
Camphor 5%
Level Select Menthol Camphor Roll On
FDA Label NDC 83191-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kandenwood Llc for the product Level Select Menthol Camphor Roll On (NDC 83191-003). 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 otc-active ingredients, otc-purpose, uses, warnings, when using this product:, stop use and ask a doctor if:, if pregnant or breastfeeding:, keep out of reach of chlidren and pets, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc-Purpose
Topical Analgesic
Uses
Temporary relief from minor aches and pains of muscles and joints, associated with strains, sprains,arthritis, backache, bruises
Warnings
For external use only
When Using This Product:
- Avoid contact with eyes, mucous membranes, and genital areas.
- Do not use on irritated, broken, or damaged skin. If redness or irritation occurs, discontinue use
- If skin is sensitive, consult a physician before use
- Do not bandage the area of application
- Do not use a heating pad with this product
- Do not use in combination with other topical products
- Do not expose appliation site to heat or direct sunlight
Stop Use And Ask A Doctor If:
- Condition worsens
- Symptoms continue for more than 7 days
- Symptoms clear up and then get worse
- You experience blistering, severe burning pain, or swelling at applicaton site
If Pregnant Or Breastfeeding:
consult a physician before use
Keep Out Of Reach Of Chlidren And Pets
If accidentally ingested, please seek medical help
Directions:
Adults and Children 12 years and older:
- Apply a thin layer of gel to affected area no more than 3-4 times daily
- Allow gel to absorb before covering area
- Wash hands, if used, after appliation with soap and water
- Consult a physician before use
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Children under 12 years of age:
Other Information:
Store in a cool, dry place iwth lid closed tightly
Inactive Ingredients:
Aesculus Hippocastanum (Horse Chestnut) Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Beta-Caryophyllene, Blue #1, Caffeine, Caprylyl Glycol, Carbomer, Cymbopogon, Flexuosus (Lemongrass Oil), Glycerin, Methylsulfonylmethane (MSM), Oleth-3, Oleth-3 Phosphate, Phenoxyethanol, Polysorbate 80, Propanediol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hydroxide, Symphytum Offcinate (Comfrey) Leaf Extract, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E) Triethanolamine, Water, Yellow #5
* Please review the disclaimer below.
