Otc - Purpose
temporarily relieves minor aches and pains of muscles and joints due to • arthritis • simple backache • strains • tendonitis • bursitis • sprains • bruises • cramps
Prohemp Soothing Menthol Rub 4%
FDA Label NDC 73769-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nature's Fusions, Llc for the product Prohemp Soothing Menthol Rub 4% (NDC 73769-100). 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 - purpose, otc - active ingredient, otc - keep out of reach of children, indications & usage, inactive ingredient, dosage & administration, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Menthol 4% - External Analgesic
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.
Indications & Usage
Adults and children 12 or older: apply to affected area as needed, no more than 4 times daily. Children under 12 years: ask a doctor.
Inactive Ingredient
aloe vera, beta caryophyllene, cellulose, hemp extract, hyaluronic acid, natural fragrances (essential oils, terpenes), organic fractionated coconut oil, potassium citrate, potassium sorbate, purified water, quillaja saponaria extract
Dosage & Administration
Adults and children 12 or older: apply to affected area as needed, no more than 4 times daily. Children under 12 years: ask a doctor.
Warnings
For external use only
When using this product
• use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or to damaged or very sensitive skin • do not bandage tightly or use with a heating pad • Stop use and ask a doctor if • excessive redness or irritation is present • condition worsens • pain persists for more than 7 days • symptoms clear up and occur again within a few days • If pregnant or breastfeeding, ask a health professional before use. • Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
4 oz jar display panel
* Please review the disclaimer below.
