Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
UberScientific, LLC
TOPICAL
OTC DRUG
For the temporary relief of local pain and discomfort associated with anorectal disorders.
OTC monograph final
UBER NUMB TOPICAL ANESTHETIC- LIDOCAINE HYDROCHLORIDE CREAM UBERSCIENTIFIC, LLC ---------- UBER NUMB TOPICAL ANESTHETIC CREAM DRUG FACTS: ACTIVE INGREDIENT: Lidocaine HCl 5.00% Local Anesthetic USES: For the temporary relief of local pain and discomfort associated with anorectal disorders. WARNINGS: For external use only. Use only as directed. WHEN USING THIS PRODUCT, do not exceed the recommended daily dosage unless directed by a doctor. DO NOT INSERT this product into rectum using fingers or any mechanical device. KEEP OUT OF REACH OF CHILDREN. Children under 12 should consult physician prior to use. STOP USING THIS PRODUCT IF: Symptoms worsen or does not improve within seven days Bleeding occurs. Redness, irritation, swelling, pain or other symptoms develop. DIRECTIONS: apply to affected area. ADULTS AND CHILDREN 12-YEARS AND OVER: consult a physician before use. CHILDREN UNDER 12, HOW TO APPLY: Clean affected area with warm water nad mild soap. Rinse thoroughly. Gently dry by patting with toilet tissue or soft cloth. Apply externally to area up to six times per day. OTHER INGREDIENTS: Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine. Store at room temperature. Avoid direct sunlight PACKAGE LABELING: UBER NUMB TOPICAL ANESTHETIC lidocaine hydrochloride cream PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:71131-774 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ALLANTOIN (UNII: 344S277G0Z) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:71131-774- Leggi il documento completo