Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Vi-Jon, LLC
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE ANHYDROUS 7 mg in 1 mL
TOPICAL
OTC DRUG
topical analgesic for the temporary relief of pain and itching associated with - minor burns - sunburn - minor cuts - scrapes - insect bites - minor skin irritations in large quantities, particularly over raw surfaces or blistered areas condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
OTC monograph not final
ALOE VERA GEL- LIDOCAINE HCL, MENTHOL GEL VI-JON, 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._ ---------- MOUNTAIN FALLS 747.001 747AB ACTIVE INGREDIENT Lidocaine HCl 0.7% Menthol 0.2% PURPOSE topical analgesic USES for the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations WARNINGS For external use only WHEN USING THIS PRODUCT avoid contact with the eyes DO NOT USE in large quantities, particularly over raw surfaces or blistered areas STOP USE AND ASK A DOCTOR IF condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away DIRECTIONS adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor INACTIVE INGREDIENTS water, alcohol, glycerin, polysorbate 80, carbomer, Aloe barbadensis leaf juice, benzophenone-4, triethanolamine, imidazolidinyl urea, blue 1 CLAIMS Made in the USA with US and foreign parts ADVERSE REACTIONS SECTION Manufactured by: Vi-Jon, LLC St. Louis, MO 63114 Questions or Comments? 1-888-593-0593 PRINCIPAL DISPLAY PANEL mountain falls cools & soothes with lidocaine & menthol relieving after sun aloe gel topical analgesic 16 FL OZ (473 mL) ALOE VERA GEL lidocaine hcl, menthol gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:11344-747 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 7 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2 mg in 1 mL Vi-Jon, LLC INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER ( Les hele dokumentet