The following Structured Product Label (SPL) was submitted to the FDA by Exclave Holdings Inc. for the product Green Remedy Cooling Roll On (NDC 78461-0002). 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 inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active 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.
Water
SD Alcohol 40-B
Spearmint Oil
Glycerin
Full Spectrum Hemp Extract
Aloe Barbadensis Leaf Extract
Holly Extract
Arnica Extract
Bamboo Extract
Pea Extract
Glucosamine HCI
Camphor
Eucalyptus Oil
Peppermint Oil
Dimethyl Sulfoxide
Silica Propylene Glycol
Triethanolamine
Carbomer
Temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, sprains, and bruises.
Shake well before use. Apply liberally to affected area. No need to rub in. Repeat if necessary, no more than 4 times daily. Rinse with soap and water to remove. Wash hands with soap and water after use. For children under 12 years of age, consult a physician.
Intended for adult use only. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Penetrating cooling relief. Temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, sprains, and bruises.
Methyl Salicylate
Menthol
Apply liberally to affected area. No need to rub in. Repeat as necessary, no more than 4 times daily.
For external use only. Keep out of eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage. Do not use with heating pad. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
89mg NDC: 78461-0002-1
89mg NDC: 78461-0002-1
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