Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)
ASCLEMED USA INC.
TOPICAL
OTC DRUG
Topical Analgesic - in large quantities, particularly over raw surfaces, or blistered areas. For the temporary relief of pain.
OTC monograph not final
ZYLOTROL MAXIMUM PAIN PATCH- LIDOCAINE 4%, MENTHOL 1% PATCH ASCLEMED USA INC. ---------- ZYLOTROL FOR PAIN CONTROL LIDOCAINE 4% AND MENTHOL 1% Lidocaine 4% Menthol 1% Topical Analgesic FOR EXTERNAL USE ONLY not intended for ingestion. in large quantities, particularly over raw surfaces, or blistered areas. Avoid contact with eyes. condition worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days. If swallowed, get medical help, or contact a Poison Control Central right away. ask a health professional before use. DIRECTIONS Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily. Children under 2 years of age: consult a doctor. Store at 20-25oC (68-77oF) and protect from moisture. polyacrylamide, vinol, sodium polyacrylate; acrylate polymerization; purified water. QUESTIONS? (310) 320-0100 USES For the temporary relief of pain. ZYLOTROL MAXIMUM PAIN PATCH lidocaine 4%, menthol 1% patch PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:76420-144(NDC:81902-101) ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) ETHENYL (UNII: PQ2K3G3591) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:76420-144- 15 15 in 1 BOX 08/20/2021 1 4 g in 1 PATCH; Type 0: Not a Combination Product ASCLEMED USA INC. MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug 505G(a)(3) 07/30/2021 LABELER - ASCLEMED USA INC. (059888437) ESTABLIS Lesen Sie das vollständige Dokument