Qc Medicated Cooling Pads 99619 For Hemorrhoidal Use 100ct

Qc Medicated Cooling Pads 99619 For Hemorrhoidal Use 100ct
SPL v6
SPL
SPL Set ID 24c49214-b333-fba4-e063-6394a90a1a70
Route
TOPICAL
Published
Effective Date 2024-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (500 mg)
Inactive Ingredients
Alcohol Propylene Glycol Citric Acid Glycerin Diazolidinyl Urea Methylparaben Propylparaben Water Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-30
Description

Active Ingredients Purpose Witch Hazel 50%..........................................................Anorectal/Astringent

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

  • adults and children 12 years of age and older:
  • when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • DO NOT FLUSH - after application, discard pad in trash and wash hands
  • apply to the affected area up to 6 times daily or after each bowel movement
  • children under 12 years of age: consult a doctor
Dosage and Administration

Distributed by: CDMA, Inc.

Novi, MI 48375

Made in China

Description

Active Ingredients Purpose Witch Hazel 50%..........................................................Anorectal/Astringent

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
  • protect from excessive heat
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
Section 50567-7

When using this product

  • ​do not use more than directed unless told to do so by a doctor
  • do not put directly in the rectum by using fingers or any mechanical device or applicator
Section 51727-6

Inactive ingredient

alcohol, citric acid, dizaolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Section 51945-4

Section 55105-1

Uses

  • temporarily relieves the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
  • temporarily relieves irritation and burning
Section 55106-9

Active Ingredients Purpose

Witch Hazel 50%..........................................................Anorectal/Astringent

Structured Label Content

Indications and Usage (34067-9)

Directions

  • adults and children 12 years of age and older:
  • when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • DO NOT FLUSH - after application, discard pad in trash and wash hands
  • apply to the affected area up to 6 times daily or after each bowel movement
  • children under 12 years of age: consult a doctor
Dosage and Administration (34068-7)

Distributed by: CDMA, Inc.

Novi, MI 48375

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
  • protect from excessive heat
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • ​do not use more than directed unless told to do so by a doctor
  • do not put directly in the rectum by using fingers or any mechanical device or applicator
Section 51727-6 (51727-6)

Inactive ingredient

alcohol, citric acid, dizaolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

  • temporarily relieves the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
  • temporarily relieves irritation and burning
Section 55106-9 (55106-9)

Active Ingredients Purpose

Witch Hazel 50%..........................................................Anorectal/Astringent

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:54.929333 · Updated: 2026-03-14T23:11:44.718615