Label: NUPERCAINAL- dibucaine ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 55741-402-02 - Packager: Dr. Reddy's Laboratories Inc.
- 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 June 15, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
Allergy alert
- 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.
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Directions
- 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
- Questions?
- PRINCIPAL DISPLAY PANEL - 56.7g Tube Box
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INGREDIENTS AND APPEARANCE
NUPERCAINAL
dibucaine ointmentProduct 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)