CVS HEMORRHOIDAL TOPICAL ANALGESIC- dibucaine ointment

CVS Hemorrhoidal Topical Analgesic by

Drug Labeling and Warnings

CVS Hemorrhoidal Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                 Purpose

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

PURPOSE

Use

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

WARNINGS

Warnings

For external use only

Allergy Alert

• Certain persons can develop allergic reactions to ingredietns in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

DO NOT USE

Do not use

• in or near the eyes
• in children under 2 years of age

WHEN USING

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

STOP USE

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve within 7 days

PREGNANCY OR BREAST FEEDING

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

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

Directions

• adults and children 12 years and over: 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
• apply externally to the affected area up to 3 or 4 times daily
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

CVS PHARMACY, INC.

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS HEMORRHOIDAL TOPICAL ANALGESIC 
dibucaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-997
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
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
WATER (UNII: 059QF0KO0R)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-997-28	1 in 1 BOX	09/12/2016
1		1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/17/2014

Labeler - CVS Pharmacy, Inc. (062312574)