Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)
Pharma Pac, LLC
TOPICAL
OTC DRUG
OTC monograph not final
BENZOCAINE AND RESORCINOL - BENZOCAINE AND RESORCINOL CREAM PHARMA PAC, 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._ ---------- DRUG FACTS ACTIVE INGREDIENTS PURPOSE Benzocaine 20%....................External Analgesic Resorcinol 3%........................External Analgesic USE TEMPORARILY RELIEVES ITCHING KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. USE temporarily relieves itching OTHER INFORMATION - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F) WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT avoid contact with the eyes 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 DO NOT APPLY over large areas of the body DIRECTIONS ADULTS AND CHILDREN 12 YEARS AND OLDER apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 to 4 times daily CHILDREN UNDER 12 YEARS ask a doctor INACTIVE INGREDIENTS aloe barbadensis leaf extract, carbomer 940, cetyl alcohol, cholecalciferol, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin alcohol, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, purified water, retinyl palmitate, sodium sulfite, tocopheryl acetate, trisodium HEDTA, trolamine, zea mays (corn) oil BENZOCAINE AND RESORCINOL benzocaine and resorcinol cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 78 6 8 -117 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5) BENZOCAINE 20 0 mg in 1 g RESO RCINO L (UNII: YUL4LO9 4HK) (RESORCINOL - UNII:YUL4LO9 4HK) RESORCINOL 20 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: Прочитајте комплетан документ