Label: NUPERCAINAL- dibucaine ointment
- 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.
Updated June 15, 2016
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
- certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, bleeding 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
- adults and children 12 years and over: if possible, 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.
- apply externally to the affected area up to 3 or 4 times daily
- children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 56.7g Tube Box
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55741-402 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) light mineral oil (UNII: N6K5787QVP) water (UNII: 059QF0KO0R) petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55741-402-02 1 in 1 BOX 05/24/2016 1 56.7 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 05/24/2016 Labeler - Dr. Reddy's Laboratories Inc. (802315887)