Nupercainal® - DailyMed Details

Nupercainal®

SPL v3

SPL

SPL Set ID bcf33951-d3a4-46c5-b208-56adc0011047

Route

TOPICAL

Published

Effective Date 2013-05-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dibucaine (1 g)

Inactive Ingredients

Acetone Sodium Bisulfite Lanolin Light Mineral Oil Water Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-05-24

Description

Drug Facts

Purpose

Hemorrhoidal ointment

Medication Information

Purpose

Hemorrhoidal ointment

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

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

Warnings

For external use only

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

Do Not Use

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

Questions?

call 1-800-790-6417

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.

Active Ingredient

Dibucaine 1%

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

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

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

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)

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Purpose

Hemorrhoidal ointment

Warnings

For external use only

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

Do Not Use (Do not use)

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

Questions?

call 1-800-790-6417

Allergy Alert (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.

Active Ingredient (Active ingredient)

Dibucaine 1%

Other Information (Other information)

store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (Stop use and ask a doctor if)

bleeding occurs
condition worsens or does not improve within 7 days

Principal Display Panel 56.7g Tube Box (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)

Advanced Ingredient Data

[{"name": "Dibucaine", "unii": "L6JW2TJG99", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "acetone sodium bisulfite", "unii": "47VY054OXY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "lanolin", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "light mineral oil", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "petrolatum", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.", "53414-9": "If pregnant or breast-feeding, ask a health care professional before use.", "Purpose": "Hemorrhoidal ointment", "Warnings": "For external use only", "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", "Do not use": "in or near the eyes in children under 2 years of age", "Questions?": "call 1-800-790-6417", "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.", "Active ingredient": "Dibucaine 1%", "Other information": "store at 20-25°C (68-77°F)", "Inactive ingredients": "acetone sodium bisulfite, lanolin, light mineral oil, purified water, white petrolatum", "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", "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:43.269971 · Updated: 2026-03-14T22:55:22.018235