Quality Choice Dibucaine Ointment 1%

SPL v2

SPL

SPL Set ID eb3fe8ef-5d98-7787-e053-2a95a90ad8b2

Route

TOPICAL

Published

Effective Date 2022-09-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dibucaine (1 g)

Inactive Ingredients

White Petrolatum Water Light Mineral Oil Lanolin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2022-09-14

Description

Dibucaine 1%

Medication Information

Indications and Usage

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

Description

Dibucaine 1%

Section 55105-1

Hemorrhoidal Ointment

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.

Packaging

Directions

Adults and children 12 years of age or older. If possible, clean the affected area by patting or blotting with appropriate cleansing wipes or with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with a tissue or a soft cloth before applying.
Apply externally to the affected area up to 3 to 4 times daily.

Children under 12 years of age. ask a doctor

Do Not Use

In or near eyes

In children under 2 years of age

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

Active Ingredient

Dibucaine 1%

Other Information

Store at room temperature 20º-25ºC (68º-77ºF)

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Questions Or Comments?

Call Toll Free 1-800-935-2362

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

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 the Reach of Children

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

Structured Label Content

Indications and Usage (34067-9)

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

Section 55105-1 (55105-1)

Hemorrhoidal Ointment

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.

Packaging

Directions

Adults and children 12 years of age or older. If possible, clean the affected area by patting or blotting with appropriate cleansing wipes or with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with a tissue or a soft cloth before applying.
Apply externally to the affected area up to 3 to 4 times daily.

Children under 12 years of age. ask a doctor

Do Not Use

In or near eyes

In children under 2 years of age

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

Active Ingredient

Dibucaine 1%

Other Information

Store at room temperature 20º-25ºC (68º-77ºF)

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Questions Or Comments? (Questions or Comments?)

Call Toll Free 1-800-935-2362

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 (Stop Use and ask a doctor)

Bleeding occurs
Condition worsens or does not improve within 7 days

If Pregnant Or Breast Feeding (If Pregnant or Breast-Feeding)

Ask a health care professional before use.

Keep Out of the Reach of Children (Keep out of the reach of Children)

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

Advanced Ingredient Data

[{"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBUCAINE", "unii": "L6JW2TJG99", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders.", "55105-1": "Hemorrhoidal Ointment", "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.", "Directions": "Adults and children 12 years of age or older. If possible, clean the affected area by patting or blotting with appropriate cleansing wipes or with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with a tissue or a soft cloth before applying. Apply externally to the affected area up to 3 to 4 times daily. Children under 12 years of age. ask a doctor", "Do Not Use": "In or near eyes In children under 2 years of age", "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", "Active Ingredient": "Dibucaine 1%", "Other Information": "Store at room temperature 20º-25ºC (68º-77ºF)", "Inactive Ingredients": "Lanolin, Light Mineral Oil, Purified Water, White Petrolatum", "Questions or Comments?": "Call Toll Free 1-800-935-2362", "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": "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 the reach of Children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:47.336569 · Updated: 2026-03-14T23:01:11.259211