Geri-care Dibucaine Ointment 1%

Geri-care Dibucaine Ointment 1%
SPL v4
SPL
SPL Set ID afe88610-5cac-960e-e053-2a95a90a7ba4
Route
TOPICAL
Published
Effective Date 2020-09-28
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 2020-09-22

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, pain, 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 with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet 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

Geri-Care Pharmaceuticals Corp.

1650 63rd Street

Brooklyn, NY 11204

1-800-540-3765

Product of China

* This product is not manufactured or distributed by the owner of the registered trademark Nupercainal®

Active Ingredient

Dibucaine 1%

Other Information
  • Store at 20º-25ºC (68º-77ºF)

Tamper-evident; do not use if foil seal is broken or missing

Inactive Ingredients

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
  • 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, pain, 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 with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet 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

Geri-Care Pharmaceuticals Corp.

1650 63rd Street

Brooklyn, NY 11204

1-800-540-3765

Product of China

* This product is not manufactured or distributed by the owner of the registered trademark Nupercainal®

Active Ingredient

Dibucaine 1%

Other Information
  • Store at 20º-25ºC (68º-77ºF)

Tamper-evident; do not use if foil seal is broken or missing

Inactive Ingredients

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 (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


Raw Label Data

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