Active Ingredients
Camphor ………………. 6%
Menthol …………….…. 4%
Ay Bendito Hemp Roll-on Gel
FDA Label NDC 72524-091
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ay Bendito International, Inc for the product Ay Bendito Hemp Roll-on (NDC 72524-091). 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, otc - purpose, use, warnings, when using this product, stop use and ask a doctor if, if pregnant of breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Use
Aid for temporary local relief of minor pain in muscles or joints.
Warnings
For external use only.
When Using This Product
- Use only as directed
- Do not bandage tightly or use with a heating pad
- Avoid contact with eyes and mucous membranes
- Do not apply to wounds or damaged, broken or irritated skin
- A transient burning sensation or redness may occur upon application but generally disappears in several days
- If you experience an allergic reaction, discontinue use and consult a doctor
- Do not expose the area treated with product to heat or direct sunlight.
Stop Use And Ask A Doctor If
Condition worsens
Redness is present
Irritation develops
Symptoms persist for more than 7 days or clear up occur again within a few days
You experience signs injury, such as pain, swelling or blistering where the product was applied.
If Pregnant Of Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and Children over 12 years of age:
Apply a small amount on the affected area.
Massage in circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.
Children under 12 years of age: do not use, consult a doctor.
Other Information
Store tightly closed in a dry place at controlled room temperature between 59°- 86° F (15°- 30° C).
Inactive Ingredient
Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Cannabis Sativa (Hemp) Seed Oil, Arnica Montana Flower Extract, Triethanolamine, Carbomer, Methyl Salicylate, Glucosamine Sulfate, Sodium Chondroitin Sulfate, Rosmarinus Officinalis (Rosemary) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue No.1 (CI 42090), FD&C Yellow No. 5.
Question Or Comments?
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