Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Joonem LLC
TOPICAL
OTC DRUG
Temporary relieves minor pain
OTC monograph not final
BASE NUMB TOPICAL ANESTHETIC- LIDOCAINE, MENTHOL SPRAY JOONEM 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._ ---------- BASE NUMB SPRAY - TOPICAL ANESTHETIC SPRAY _DRUG FACTS_ _ACTIVE INGREDIENTS_ Lidocaine 4% Menthol 1% _PURPOSE_ Topical Analgesic _INDICATIONS:_ Temporary relieves minor pain _WARNINGS:_ Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician Do not apply to wounds or damaged skin. Do not bandage tightly. Do not use in large quantities, particularly over raw surfaces or blistered areas. KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL INGESTION! If swallowed, get medical help or contact a poison control center immediately. _DIRECTIONS:_ use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 12 years of age: consult a doctor _OTHER INFORMATION:_ Store at 20 to 25 C (68 to 77 F) _INACTIVE INGREDIENTS:_ L-arginine, Sodium Benzoate, Rectified Spirit, Disodium EDTA, Phenoxyethanol, Polysorbate 20, DM Water PACKAGE LABELING: BASE NUMB TOPICAL ANESTHETIC lidocaine, menthol spray PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:80327-003 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY Joonem LLC INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ARGININE (UNII: 94ZLA3W45F) SODIUM BENZOATE (UNII: OJ245FE5EU) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION M Læs hele dokumentet