País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
DirectRx
TOPICAL
OTC DRUG
Topical Analgesic Do not use in large quantities, particularly over raw surfaces, or blistered areas.
OTC monograph not final
EXIGENCE ONE PATCH- EXIGENCE ONE PATCH PATCH DIRECTRX _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._ ---------- EXIGENCE ONE PATCH Topical Analgesic For external use only not intended for ingestion. Do not use in large quantities, particularly over raw surfaces, or blistered areas. Avoid contact with the eyes. Stop use and ask doctor if 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. 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 20-25 oC (68-77 oF) and protect from moisture. polyacrylamide, vinol, sodium polyacrylate; acrylate polymerization, purified water. Questions? (310) 320-0100 Lidocaine 4% Menthol 1% EXIGENCE ONE PATCH exigence one patch patch PRODUCT INFORMATION DirectRx PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:72189-296(NDC:81902-102) ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) ETHENYL (UNII: PQ2K3G3591) WATER (UNII: 059QF0KO0R) ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:72189-296- 01 4 g in 1 PATCH; Type 0: Not a Combination Product 12/02/2021 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE M Llegiu el document complet