NUPERCAINAL- dibucaine ointment

Nupercainal by

Drug Labeling and Warnings

Nupercainal by is a Otc medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Dibucaine 1%

Purpose

Hemorrhoidal ointment

Use

• temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders

Warnings

For external use only

Allergy alert

• certain persons can develop allergic reactions to ingredients in this product. If the symptom 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

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

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 and ask a doctor if

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

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

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

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

Questions?

call 1-800-790-6417

PRINCIPAL DISPLAY PANEL - 56.7g Tube Box

LONGEST LASTING
INGREDIENT

UP TO 8 HOURS

NDC: 55741-402-02

NUPERCAINAL®
HEMORRHOIDAL OINTMENT
DIBUCAINE 1%

Fast Temporary Relief of Pain, Itching,
and Burning Due to Hemorrhoids.

NET WT 2 oz. (56.7g)

INGREDIENTS AND APPEARANCE

NUPERCAINAL 
dibucaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55741-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dibucaine (UNII: L6JW2TJG99) (Dibucaine - UNII:L6JW2TJG99)	Dibucaine	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
acetone sodium bisulfite (UNII: 47VY054OXY)
lanolin (UNII: 7EV65EAW6H)
light mineral oil (UNII: N6K5787QVP)
water (UNII: 059QF0KO0R)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55741-402-02	1 in 1 BOX	05/24/2016
1		56.7 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	05/24/2016

Labeler - Dr. Reddy's Laboratories Inc. (802315887)