DIBUCAINE - dibucaine cream 
CVS Pharmacy

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.

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drug facts

Active ingredients                                 Purpose

Dibucaine 1%...............................................Hemorrhoidal/Local analgesic ointment


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. If swallowed, get medical help or contact
a Poison Control Center right away.


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)


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


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 Ingredients

acetone sodium bisulfite, lanolin, light mineral oil, purified water, white petrolatum

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DIBUCAINE 
dibucaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-398
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
ACETONE SODIUM BISULFITE (UNII: 47VY054OXY)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-398-031 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/16/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: d7142db6-14d7-43ab-b0dd-64459a2be200
Set id: e3807a1b-c375-456a-bd7e-de3a1607c8fc
Version: 1
Effective Time: 20100716
 
CVS Pharmacy