Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
1st Class Pharmaceuticals, Inc.
TOPICAL
OTC DRUG
Topical Analgesic Topical Analgesic For temporary relieft of pain associated with minor burns, minor cuts, scrapes, insect bites or skin irritations. - If symptoms persist for more than seven days, discontinue use and consult physician.
OTC monograph not final
1ST RELIEF TOPICAL- LIDOCAINE AND MENTHOL SPRAY 1ST CLASS PHARMACEUTICALS, INC. _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._ ---------- 1ST RELIEF TOPICAL ACTIVE INGREDIENT: Lidocaine 4.00% Menthol 1.00% Topical Analgesic Topical Analgesic INDICATIONS : For temporary relieft of pain associated with minor burns, minor cuts, scrapes, insect bites or skin irritations. WARNINGS : For external use only Avoid contact with eyes Do not apply to open wounds or damages skin. If symptoms persist for more than seven days, discontinue use and consult physician. Keep out of reach of children. If swallowed, conslut physician. DIRECTIONS Apply directly to affected area. Do not use more than four times per day. Children under two-years of age: consult a physician. OTHER INGREDIENTS: Aqua (Deionized Water), ARNICA MONTANA,BOSWELLIA SERRATA, CETYL MYRISTOLEATE, EMU OIL, GLYCYRRHIZA GLABRA, METHYLSULFONYLMETHANE (MSM), POLYSORBATE 20, POTASSIUM SORBATE, SD-Alcohol 40B, SODIUM BENZOATE If pregnant or breast feeding, contact physician prior to use. PACKAGE LABEL NDC 69094-226-04 1st Class PHARMACEUTICALS INC. 1st RELIEF TOPICAL SPRAY For temporary relief of: • backache • bruises • arthritis • sprains 4 Fl OZ. (118 ml) Distributed by: 1st Class PHARMACEUTICALS INC. Los Angeles, CA 90064 www.1stclass pharmaceuticals.com 1ST RELIEF TOPICAL lidocaine and menthol spray PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 0 9 4-226 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH 1st Class Pharmaceuticals, Inc. LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7) LIDOCAINE 40 mg in 1 mL MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A) MENTHOL 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) ARNICA MO NTANA FLO WER (UNII: Baca dokumen lengkap