Country: United States
Language: English
Source: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Joonem LLC
TOPICAL
OTC DRUG
For the temporary relief of pain and discomfort associated with anorectal disorders
OTC monograph final
BASE LABORATORIES BASE NUMB TOPICAL ANORECTAL CREAM- LIDOCAINE CREAM JOONEM LLC ---------- BASE LABORATORIES BASE NUMB TOPICAL ANORECTAL CREAM _DRUG FACTS_ _ACTIVE INGREDIENTS_ Lidocaine 5% _PURPOSE_ Topical Analgesic _INDICATIONS:_ For the temporary relief of pain and discomfort associated with anorectal disorders _WARNINGS:_ If condition worsens or does not improve within 7 days, consult a doctor. Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor. KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL INGESTION! If swallowed, get medical help or contact a posion control center immediately. _DIRECTIONS:_ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally to the affected area up to 6 times daily. Children under 12 years of age: consult a doctor INACTIVE INGREDIENTS: Hemp Seed Oil, Chamomile, Aloe Vera, Tea Tree Oil, Menthol, Glycerol, Propylene Glycol, Water, Cetearyl Alcohol, Cetearyl Glucoside, Glyceryl Stearate, Polydimethylsiloxane, (350 viscosity), 26 White Oil, 305, PEG-100, GPL PACKAGE LABELING: BASE LABORATORIES BASE NUMB TOPICAL ANORECTAL CREAM lidocaine cream PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:80327-008 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CANNA Read the complete document