Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)
Geri-Care Pharmaceuticals, Corp
TOPICAL
OTC DRUG
Hemorrhoidal Ointment Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders. - Bleeding occurs - Condition worsens or does not improve within 7 days In or near eyes In children under 2 years of age
OTC monograph final
DIBUCAINE- DIBUCAINE 1% OINTMENT GERI-CARE PHARMACEUTICALS, CORP ---------- GERI-CARE DIBUCAINE OINTMENT 1% _DRUG FACTS_ _ACTIVE INGREDIENT_ Dibucaine 1% Hemorrhoidal Ointment Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders. IF PREGNANT OR BREAST-FEEDING Ask a health care professional before use. _STOP USE AND ASK A DOCTOR_ Bleeding occurs Condition worsens or does not improve within 7 days _KEEP OUT OF THE REACH OF CHILDREN_ If swallowed, get medical help or contact a Poison Control Center right away. DO NOT USE In or near eyes In children under 2 years of age WARNINGS For External use only Allergy alert Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and ask a doctor. WHEN USING THIS PRODUCT Do not use more than directed unless directed by a doctor Do not put this product into the rectum by using fingers or any mechanical device or applicator. _DIRECTIONS_ Adults and children 12 years of age or older. If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet tissue or a soft cloth before applying. Apply externally to the affected area up to 3 to 4 times daily. Children under 12 years of age. ask a doctor _OTHER INFORMATION_ Store at 20º-25ºC (68º-77ºF) Tamper-evident; do not use if foil seal is broken or missing _INACTIVE INGREDIENTS_ Lanolin, Light Mineral Oil, Purified Water, White Petrolatum DISTRIBUTED BY Geri-Care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204 1-800-540-3765 Product of China * This product is not manufactured or distributed by the owner of the registered trademark Nupercainal® PACKAGING DIBUCAINE dibucaine 1% ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:57896-131 Geri-Care Pharmaceuticals, Corp ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGRE Read the complete document