The following Structured Product Label (SPL) was submitted to the FDA by Cool Buffalo, Inc. for the product Cool Buffalo Gel (NDC 87758-0001). 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 - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients
2 oz contains 1.638% of Arnica 30C, Bellis 12X, Calc fluor 30X, Ferrum phos 30X, Hypericum 30C, Ledum 12X, Nat sulphuricum 30C, Rhus tox 30X, Sulphuricum ac 12X, Symphytum 6X; 0.54% of Arnica 1X, Calendula 1X, Hypericum 1X.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Uses
Temporary relief of pain related to bruises, sunburns, muscle aches, sprains, strains, joints, skin irritations, insect bites, and minor burns.
Warnings
Directions
Other Information
Inactive Ingredients
Aloe Barbadensis (Aloe Vera) Leaf Juice, Purified Water, Ethanol, Carbomer, remaining ingredients at ≤ 1%: Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide.
Distributed by Cool Buffalo, Inc.
Dahlonega, GA 30533
Questions? Comments?
866.507.3128
www.coolbuffalo.com
Cool Buffalo Gel
Topical, homeopathic pain-relief gel
Pain related to bruises,
sunburns, muscle aches
sprains, strains, joints,
skin irritations, insect bites,
and minor burns
2 oz (56.7 g)
Purpose Temporary relief of pain related to bruises, sunburns, muscle aches, sprains, strains, joints, skin irritations, insect bites, and minor burns.
* Please review the disclaimer below.
