Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)
RB Health (US) LLC
TOPICAL
OTC DRUG
Temporarily relieves minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - bruises - sprains
OTC monograph not final
PERFORM COOL AND SOOTHING PAIN RELIEVING- MENTHOL GEL RB HEALTH (US) 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._ ---------- PERFORM COOL AND SOOTHING PAIN RELIEVING DRUG FACTS ACTIVE INGREDIENT Menthol 3.5% PURPOSE Pain Relieving Gel USES Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE: KEEP AWAY FROM EXCESSIVE HEAT OR OPEN FLAME WHEN USING THIS PRODUCT use only as directed avoid contact with the eyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device STOP USE AND ASK A DOCTOR IF you experience pain, swelling or blistering of the skin condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ® arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age 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 right away. DIRECTIONS adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician wash hands after use with cool water OTHER INFORMATION store at 20-25°C (68-77°F) store in a cool dry place away from direct sunlight INACTIVE INGREDIENTS Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Blue 1, Camellia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (Lime) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, Hypericum Perforatum Oil, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Lavandula Hybrid Read the complete document