Label: DIBUCAINE- dibucaine 1% ointment
- NDC Code(s): 69396-023-01
- Packager: Trifecta Pharmaceuticals USA LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 2, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- PURPOSE
- INDICATIONS & USAGE
- If Pregnant or Breast-Feeding
- Stop Use and ask a doctor
- Keep out of the reach of Children
- Do Not Use
- Warnings
- When using this product
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Directions
- Adults and children 12 years of age or older. If possible, clean the affected area by platting or blotting with an appropriate cleansing wipe, gently dry by patting or blotting with a 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
- Questions or Comments?
- Other Information
- Inactive Ingredients
- Distributed By
- Packaging
-
INGREDIENTS AND APPEARANCE
DIBUCAINE
dibucaine 1% ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-023 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 PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) LIGHT MINERAL OIL (UNII: N6K5787QVP) LANOLIN (UNII: 7EV65EAW6H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-023-01 1 in 1 BOX 09/14/2022 1 28.4 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 Drug M017 09/14/2022 Labeler - Trifecta Pharmaceuticals USA LLC (079424163) Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)