מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Handyman Stuff, LLC
TOPICAL
OTC DRUG
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.
OTC monograph not final
HANDYMAN FREEZE PAIN RELIEF- MENTHOL GEL HANDYMAN STUFF, LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- HANDYMAN FREEZE PAIN RELIEF GEL DRUG FACTS: ACTIVE INGREDIENT: Menthol 4.00% Topical Analgesic INDICATIONS : For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains. WARNINGS : For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician. KEEP OUT OF REACH OF CHILDREN. If swallowed, consult physician. DO NOT APPLY to wounds or damaged skin. Do not bandage tightly. IF PREGNANT OR BREAST FEEDING, contact physician prior to use. DIRECTIONS : Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physcian. ADDITIONAL INFORMATION: Store at room temperature. OTHER INGREDIENTS: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arcticum Lappa (Burdock) Root Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glucosamine Sulfate, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Myristate, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E), Triethanolamine, FD&C Blue #1, FD&C Yellow #5. PACKAGE LABELING: HANDYMAN FREEZE PAIN RELIEF menthol gel Handyman Stuff, LLC PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:7310 3-119 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A) MENTHOL 40 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH AL קרא את המסמך השלם