CVS HEMORRHOIDAL TOPICAL ANALGESIC- dibucaine ointment 
CVS Pharmacy, Inc.

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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Active Ingredient                                 Purpose

Dibucaine 1%...................................... Local anesthetic

Use

temporarily relives pain and itching due to hemorrhoids or other anorectal disorders

Warnings

For external use only

Allergy Alert

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

disodium EDTA, distilled water, lanolin, mineral oil, white petrolatum

DISTRIBUTED BY:

CVS PHARMACY, INC.

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

image description

CVS HEMORRHOIDAL TOPICAL ANALGESIC 
dibucaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-997
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
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
WATER (UNII: 059QF0KO0R)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-997-281 in 1 BOX09/12/2016
11 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/17/2014
Labeler - CVS Pharmacy, Inc. (062312574)

Revised: 9/2016
Document Id: df77c649-1fcb-4a6a-abf6-e3440b76a77c
Set id: bbe57d90-36d6-4d81-afe0-39d2268e5c8c
Version: 2
Effective Time: 20160912
 
CVS Pharmacy, Inc.