Cooling & Soothing

Cooling & Soothing
SPL v5
SPL
SPL Set ID 936a0cca-5049-4ddf-9581-75c2da6d9cfa
Route
RECTAL
Published
Effective Date 2023-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (50 g)
Inactive Ingredients
Imidurea Methylparaben Propylparaben Sodium Citrate Water Anhydrous Citric Acid Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-13

Description

Witch Hazel 50% Purpose: Hemorrhoidal Astringent


Medication Information

Dosage and Administration
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • Apply externally to the affected area up to 6 times daily or after each bowel movement 
  • After application, discard pad Children under 12 years of age: consult a doctor
Description

Witch Hazel 50% Purpose: Hemorrhoidal Astringent

Uses

For temporary relief of local discomfort,

burning and irritation associated with Hemorrhoids

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

  • If swallowed, get medical attention or contact the Poison Control Center immediately.
Section 51945-4

Warnings

For External Use Only

  • Avoid contact with the eyes

Consult a doctor

  • If condition worsens or does not improve within 7 days
  • In case of bleeding
  • Before exceeding the recommended dosage

DO NOTput this product into the rectum using fingers or any mechanical device.

Drug Facts

Witch Hazel 50%

Purpose: Hemorrhoidal Astringent

Directions:
  • When practical, clean the affected area with mild soap and warm water, and rinse thoroughly
Other Information
  • Store at room temperature 15°-30°C (59°-86°F)
  • If adverse effects call 1-877-225-6999
Other Ingredients

Alcohol, Citric Acid, Deionized Water, DMDM Hydantoin,Glycerin, Sodium Citrate.


Structured Label Content

Uses

For temporary relief of local discomfort,

burning and irritation associated with Hemorrhoids

Dosage and Administration (34068-7)
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • Apply externally to the affected area up to 6 times daily or after each bowel movement 
  • After application, discard pad Children under 12 years of age: consult a doctor
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

  • If swallowed, get medical attention or contact the Poison Control Center immediately.
Section 51945-4 (51945-4)

Warnings (WARNINGS)

For External Use Only

  • Avoid contact with the eyes

Consult a doctor

  • If condition worsens or does not improve within 7 days
  • In case of bleeding
  • Before exceeding the recommended dosage

DO NOTput this product into the rectum using fingers or any mechanical device.

Drug Facts

Witch Hazel 50%

Purpose: Hemorrhoidal Astringent

Directions:
  • When practical, clean the affected area with mild soap and warm water, and rinse thoroughly
Other Information
  • Store at room temperature 15°-30°C (59°-86°F)
  • If adverse effects call 1-877-225-6999
Other Ingredients

Alcohol, Citric Acid, Deionized Water, DMDM Hydantoin,Glycerin, Sodium Citrate.


Advanced Ingredient Data


Raw Label Data

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