البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Village Pharma, LLC
TOPICAL
OTC DRUG
For Temporary relief of pain
OTC monograph not final
LIDOZEN- LIDOCAINE HYDROCHLORIDE, MENTHOL PATCH VILLAGE PHARMA, 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._ ---------- LIDOZEN PATCH DRUG FACTS: ACTIVE INGREDIENTS: Lidocaine HCL 4.00% Menthol 1.00% Topical Anesthetic External Analgesic USES: For Temporary relief of pain WARNINGS For external use only. Avoid contact with eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. DO NOT USE in large quantities, particularly over raw surfaces or blistered areas. 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 OVER 12 YEARS): Clean and dry affected area. Remove patch from backing and apply to affected area. Use only one patch at a time, and maximum of four patches / day. Leave patch on affected area for up to 8-hours. Do not use patches for longer than five consecutive days. Children under 12 should consult physician prior to use. INACTIVE INGREDIENTS: Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbte-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5 Store below 25 degrees Celsius. Avoid direct sunlight. PACKAGE LABELING: LIDOZEN lidocaine hydrochloride, menthol patch PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:71574-400 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE اقرأ الوثيقة كاملة