Active Ingredient(S)
Menthol 4%
The following Structured Product Label (SPL) was submitted to the FDA by Garcoa, Inc. for the product Blue Goo Freezing Pain Relief (NDC 67385-286). 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 ingredient(s), purpose, use(s), warnings, directions, inactive ingredients, questions, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Menthol 4%
Topical analgesic
Use for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains.
WARNINGS
For external use only.
Ask a doctor if you have sensitive skin.
When using this product • Avoid contact with the eyes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage tightly • Wash hands after use with cool water • Do not use with heating pads or heating devices.
Stop use and consult a doctor if • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
Flammable • keep away from fire or flame.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions Adults and children 6 years age and older: Apply to affected area not more than 3 -4 times daily. Massage not necessary. • Children under 6 years of age: Do Not Use. Consult a Doctor.
Inactive ingredients Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Blue 1, Boswellia Serrata Resin Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Silica, Sodium Hydroxide, Tocopheryl Acetate, Water, Yellow 5
Question or comments? 1-866-567-8600
* Please review the disclaimer below.