Label: DIBUCAINE- dibucaine 1% ointment
- NDC Code(s): 63868-911-01
- Packager: Chain Drug Marketing Association Inc.
- Category: HUMAN OTC DRUG LABEL
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 May 23, 2023
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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 patting or blotting with appropriate cleansing wipes or with mild soap and warm water and rinse thoroughly. 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
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INGREDIENTS AND APPEARANCE
DIBUCAINE
dibucaine 1% ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-911 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 WHITE PETROLATUM (UNII: B6E5W8RQJ4) WATER (UNII: 059QF0KO0R) LIGHT MINERAL OIL (UNII: N6K5787QVP) LANOLIN (UNII: 7EV65EAW6H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-911-01 1 in 1 BOX 09/14/2022 1 28.3 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 09/14/2022 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)