DIBUCAINE by CVS Pharmacy / Pharma Pac, LLC DIBUCAINE cream

DIBUCAINE by

Drug Labeling and Warnings

DIBUCAINE by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                 Purpose

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

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

Keep out of reach of children. If swallowed, get medical help or contact
a Poison Control Center right away.

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)

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

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

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIBUCAINE 
dibucaine cream

Product 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