Globe Dibucaine Ointment 1%

SPL v2

SPL

SPL Set ID e8a56651-a292-7609-e053-2a95a90a7c36

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

Petrolatum Water Light Mineral Oil Lanolin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG 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 platting or blotting with an appropriate cleansing wipe, 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

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

Made in China

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

Child Resistant Packaging

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 1-888-296-9067

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 platting or blotting with an appropriate cleansing wipe, 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

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

Made in China

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

Child Resistant Packaging

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 1-888-296-9067

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": "PETROLATUM", "unii": "4T6H12BN9U", "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 platting or blotting with an appropriate cleansing wipe, 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": "Trifecta Pharmaceuticals USA 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA 1-888-296-9067 Made in China * This product is not manufactured or distributed by Ducere Pharma, Distributor of Nuper-Cainal Child Resistant Packaging", "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 1-888-296-9067", "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: 2026-02-15T12:02:38.837606 · Updated: 2026-03-14T23:02:19.584479