Joy Skin And Body Premium Pain Relieving
FDA Label NDC 80977-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Joy Organics Llc for the product Joy Skin And Body Premium Pain Relieving (NDC 80977-101). 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 drug facts, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 4%
Purpose
External analgesic
Use
For the temporary relief of minor aches and pains of the muscles and joints associated with
• arthritis • simple backache • sprains • strains • bruises
Warnings
Flammable: Keep away from fire or flame
For external use only.
Do not use
• on wounds or damaged skin.
When using this product
• avoid contact with the eyes. If contact occurs, rinse with water to remove
• do not bandage tightly
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
If pregnant or breast-feeding, ask a health professional before use.
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 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• children under 2 years of age: consult a doctor.
Other Information
• protect this product from excessive heat and direct sun.
• store at room temperature.
Inactive Ingredients
Calcium Gluconate, Camphor(Cinnamomum camphora) Oil (0.5%), Cetearyl Glucoside, Cetyl Alcohol, Glucono delta-lactone, Hemp (Cannabis sativa) Extract, Organic Aloe Vera Leaf Juice (0.02%), Organic Glycerin (3%), Organic Lavender(Lavandula angustifolia) Oil (0.1%), Organic Olive(Olea europaea) Oil (10%), Organic Peppermint(Mentha piperita) Oil (0.1%), Organic Rosemary(Rosmarinus officinalis) Oil (0.1%), Organic Sweet Marjoram(Origanum majorana) Oil (0.1%), Organic Wintergreen(Gaultheria procumbens) Oil (0.1%), Potassium Sorbate, Safflower (Carthamus tinctorius) Oleosomes Extract, Sodium Benzoate, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopherol, Water(Aqua), Xanthan Gum.
Questions? +1-833-569-7223
You may also report serious side effects to this phone number.
Mon - Fri: 9 AM to 5 PM
Packaging
Image (80977 101 1)
* Please review the disclaimer below.
