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 GEL VILLAGE PHARMA, LLC ---------- LIDOZEN GEL 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. ask a health professional before use. IF PREGNANT OR BREAST-FEEDING, 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): Apply directly to affected area. Do not use more than four times per day. 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 PACKAGE LABELING: LIDOZEN lidocaine hydrochloride, menthol gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:71574-300 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 40 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA (UNII: O80TY208ZW) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I7 Прочитать полный документ