Label: CVS HEMORRHOIDAL TOPICAL ANALGESIC- dibucaine ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-997-28 - Packager: CVS Pharmacy, 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 September 12, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS HEMORRHOIDAL TOPICAL ANALGESIC
dibucaine ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-997 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength DISODIUM EDTA-COPPER (UNII: 6V475AX06U) WATER (UNII: 059QF0KO0R) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-997-28 1 in 1 BOX 09/12/2016 1 1 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 01/17/2014 Labeler - CVS Pharmacy, Inc. (062312574)