ประเทศ: สหรัฐอเมริกา
ภาษา: อังกฤษ
แหล่งที่มา: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (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 PATCH- LIDOCAINE, MENTHOL PATCH VILLAGE PHARMA LLC ---------- LIDOZEN PATCH DRUG FACTS: ACTIVE INGREDIENTS: Lidocaine 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 Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben STORE BELOW 25 DEGREES CELSIUS. AVOID DIRECT SUNLIGHT. PACKAGE LABELING: LIDOZEN PATCH lidocaine, menthol patch PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:71574-905 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TARTARIC ACID (UNII: W4888I119H) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) METHYLPARABEN (UNII: A2I8C7HI9T) Village Pharma LLC PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE M อ่านเอกสารฉบับเต็ม