Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Pharmadel LLC
TOPICAL
OTC DRUG
For the temporary relief of minor aches and pains of muscles and joints associated with: - arthritis - simple backache - muscle strains - sprains - bruises
OTC monograph final
FLEXSPORT ROLL ON- METHYL SALICYLATE LIQUID PHARMADEL 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._ ---------- FLEXSPORT ROLL ON - MS 15% DRUG FACTS ACTIVE INGREDIENT AND PURPOSE ACTIVE INGREDIENT PURPOSE Menthol 16% .................... Topical analgesic USES For the temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache muscle strains sprains bruises WARNINGS FOR EXTERNAL USE ONLY. AVOID CONTACT WITH THE EYES. FLAMMABLE: KEEP AWAY FROM FIRE OR FLAME. WHEN USING THIS PRODUCT do not bandage tightly or use with a heating pad do not apply to wounds or damaged, broken or irritated skin STOP USE AND ASK A DOCTOR IF condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days 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 USE ONLY AS DIRECTED ADULTS AND CHILDREN OVER 12 YEARS: apply to affected area not more than 3 to 4 times daily CHILDREN UNDER 12 YEARS OF AGE: ask a doctor OTHER INFORMATION store at temperatures not exceeding 15°–30°C (59°– 86°F) avoid excessive heat and humidity INACTIVE INGREDIENTS acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, capsaicin, glycerin, isopropyl myristate, propylene glycol, trolamine, water QUESTIONS OR COMMENTS? 1-866-359-3478 (M-F) 9 AM – 5 PM EST or www.pharmadel.com PRINCIPAL DISPLAY PANEL Topical Analgesic Liquid FLEXSPORT Pain Relief ROLL-ON Muscle & Joint Pain Backaches Arthritis 3 fl oz (89 mL) FLEXSPORT ROLL ON methyl salicylate liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:55758-360 ROUTE OF ADMINISTRATION TOPICAL Pharmadel LLC ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH Prečítajte si celý dokument