Label: DIBUCAINE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-398-03 - Packager: CVS Pharmacy
- 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 July 16, 2010
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- ACTIVE INGREDIENT
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PURPOSE
Active ingredients Purpose
Dibucaine 1%...............................................Hemorrhoidal/Local analgesic ointment
Uses temporarily relieves pain and itching due to:
- hemorrhoids or other anorectal disorders - sunburn - minor burns - minor cuts
- scrapes - insect bites - minor skin irritation
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Uses temporarily relieves pain and itching due to:
- hemorrhoids or other anorectal disorders - sunburn - minor burns - minor cuts
- scrapes - insect bites - minor skin irritation
Other information
- to secure child resistant cap; screw cap tightly. Then turn cap in opposite direction.
If clicking sound is not heard, repeat procedure.
- see crimp of tube for lot number and expiration date
-store at controlled room temperature 20 degrees to 25 degrees c (68 degrees to 77 degrees F)
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WARNINGS
Warnings
For external use only.
Allergy alert - certain persons san develop allergic reactions to ingredients in this product
Do not use
- in or near the eyes
- do not get into the eyes
- in infants under 2 years of age
- in large quantities, particularly over raw surfaces or blistered areas
- do not put this product into rectum by using fingers or any mechanical device
Stop use and ask a doctor if
- condition worsens, or does not improve within 7 days
- the symptom being treated does not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase
If pregnant or breast feeding, as a health care professional before use
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away
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DOSAGE & ADMINISTRATION
Directions
- 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
Adults and children 12 and over - apply externally to the affected area up to 3 to 4 times a day.
Children under 2 - 12 years of age - ask a doctor
Infants under 2 years of age - DO NOT USE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIBUCAINE
dibucaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-398 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 LANOLIN (UNII: 7EV65EAW6H) ACETONE SODIUM BISULFITE (UNII: 47VY054OXY) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-398-03 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/16/2010 Labeler - CVS Pharmacy (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture
