Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Pharmadel LLC
TOPICAL
OTC DRUG
Purpose External Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - sprains
OTC monograph not final
KOFAL- METHYL SALICYLATE OINTMENT 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._ ---------- KOFAL FUERTE OINTMENT 2 OZ (SKOTT) _ACTIVE INGREDIENTS & PURPOSE_ PURPOSE External Analgesic _ACTIVE INGREDIENT_ _PURPOSE_ Methyl Salicylate 10.5%............................. External Analgesic _USES_ For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains sprains _WARNINGS_ FOR EXTERNAL USE ONLY. Avoid contact with the eyes. _DO NOT USE_ on broken or irritated skin with a tight bandage with a heating pad STOP USE AND ASK DOCTOR IMMEDIATELY IF condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days excessive skin irritation occurs IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed get medical help, or contact a Poison Control Center immediately. _DIRECTIONS_ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor _OTHER INFORMATION_ store between 59° to 86°F (15° to 25°C) do not use if clear seal over jar is broken, torn or missing _INACTIVE INGREDIENTS_ camphor, menthol, methylparaben, paraffin, petrolatum, propylparaben. _QUESTIONS OR COMMENTS?_ 1-866-359-3478 M-F 9 AM - 5 PM EST or www.pharmadel.com DISTRIBUTED BY/ DISTRIBUIDO POR: Pharmadel LLC, Georgetown, DE 199747 PACKAGE LABEL & PRINCIPAL DISPLAY PANEL KOFAL methyl salicylate ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:55758-109 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH Pharmadel LLC METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ 4LPZ ) METHYL SALICYLATE 10.5 g in 100 g INACTIVE INGREDIENTS INGRED Lees het volledige document