DIBUCAINE- dibucaine 1% ointment 
Chain Drug Marketing Association 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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Quality Choice Dibucaine Ointment 1%

Drug Facts

Active Ingredient

Dibucaine 1%

Hemorrhoidal Ointment

Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders.

If Pregnant or Breast-Feeding

Ask a health care professional before use.

Stop Use and ask a doctor

Keep out of the reach of Children

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

Do Not Use

In or near eyes

In children under 2 years of age

Warnings

For External use only

Allergy alert

Certain persons can develop allergic reactions to ingredients in this product.

If the symptoms being treated do not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

When using this product

Do not use more than directed unless directed by a doctor

Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Directions

Children under 12 years of age. ask a doctor

Questions or Comments?

Call Toll Free 1-800-935-2362

Other Information

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Distributed By

Distributed by: CDMA, Inc.

Novi, MI 48375 USA

1-800-935-2362

* This product is not manufactured or distributed by Ducere Pharma, Distributor of Nuper-Cainal

Packaging

qc-dibucaine-1oz-CDER 2

DIBUCAINE 
dibucaine 1% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-911
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
WATER (UNII: 059QF0KO0R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
LANOLIN (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-911-011 in 1 BOX09/14/2022
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/14/2022
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)

Revised: 5/2023
Document Id: fc61847b-cb64-97b1-e053-6394a90ae1b9
Set id: eb3fe8ef-5d98-7787-e053-2a95a90ad8b2
Version: 2
Effective Time: 20230523
 
Chain Drug Marketing Association Inc.