Label: DIBUCAINE ointment
- NDC Code(s): 45802-050-03
- Packager: Padagis Israel Pharmaceuticals Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 10, 2021
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- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Allergy warning: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and ask a doctor.
When using this product
for hemorrhoidal:
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- do not exceed the recommended daily dosage unless directed by a doctor
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- do not put this product into the rectum by using fingers or any mechanical device or applicator
for topical analgesic:
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- do not use in large quantities, particularly over raw surfaces or blistered areas
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Directions
for hemorrhoidal:
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- adults and children 12 years & older: when practical, clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
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- apply externally to the affected area up to 3 or 4 times daily
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- children under 12 years of age: ask a doctor
for topical analgesic:
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- adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
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- children under 2 years of age: ask a doctor
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
DIBUCAINE
dibucaine ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE 1 g in 100 g Inactive Ingredients Ingredient Name Strength ACETONE SODIUM BISULFITE (UNII: 47VY054OXY) LANOLIN (UNII: 7EV65EAW6H) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-050-03 1 in 1 CARTON 06/20/2011 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 06/20/2011 Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)