Страна: Соединенные Штаты
Язык: английский
Источник: 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 ---------- LIDOZEN PATCH DRUG FACTS: ACTIVE INGREDIENTS: Lidocaine HCL 4.00% Menthol 1.00% Toplcal 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 consective days. Children under 12 should consult physician prior to use. INACTIVE INGREDIENTS: Propylene Glycol, Carboxymethyl Cellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Polysorbate 80, Polyvinylpyrrolidone 90, Tartaric Acid, Tetrasodium Edetate, Titanium Dioxide, Hydrogenated Castor Oil, Phenoxyethanol, Urea, Water. Store below 25 degrees Celsius. Avoid directed sunlight. PACKAGE LABELING: LIDOZEN lidocaine hydrochloride, menthol patch PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:71574-800 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 1 g Village Pharma LLC INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) DIHY Прочитать полный документ