Tucks Medicated Cooling Pads: Package Insert and Label Information

TUCKS MEDICATED COOLING PADS- witch hazel cloth
McNEIL-PPC, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Witch Hazel 50%

Purpose

Astringent

Use

  • temporary relieves the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
  • temporarily relieves itching and burning

Warnings

For external use only

When using this product

  • do not use more than directed unless told to do so by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults:
    • when practical, cleanse the affected area with mild soap and warm water, and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply externally to the affected are up to 6 times daily or after each bowel movement
    • after application, discard pad
  • children under 12 years of age: ask a doctor

Other information

  • store at 68 to 77°F (20 to 25°C)

Inactive ingredients

water, glycerin, alcohol, propylene glycol, sodium citrate, diazolidinyl urea, citric acid, methylparaben, proplyparaben

Questions?

call toll-free 800-223-0182, weekdays, 9 AM- 5 PM EST

Distributed by: McNEIL-PPC, Inc.
Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL — 40 Pad Jar Carton

TUCKS®

MEDICATED COOLING PADS

HEMORRHOIDAL PADS WITH WITCH HAZEL

immediate relief from burning and itching caused by hemorrhoids

witch hazel soothes and Protects irritated areas

40 PADS 3.0 sq. in. (7.6 sq. cm)

PRINCIPAL DISPLAY PANEL -- 40 Pad Jar Carton
(click image for full-size original)
TUCKS MEDICATED COOLING PADS
witch hazel cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30014-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Witch Hazel (Witch Hazel) Witch Hazel 500 mg
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Alcohol
Propylene Glycol
Sodium Citrate
Diazolidinyl Urea
Citric Acid Monohydrate
Methylparaben
Propylparaben
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30014-102-40 1 JAR in 1 CARTON contains a JAR
1 40 CLOTH in 1 JAR This package is contained within the CARTON (30014-102-40)
2 NDC:30014-102-99 1 JAR in 1 CARTON contains a JAR
2 100 CLOTH in 1 JAR This package is contained within the CARTON (30014-102-99)
3 NDC:30014-102-94 2 CARTON in 1 PACKAGE, COMBINATION contains a CARTON
3 1 JAR in 1 CARTON This package is contained within the PACKAGE, COMBINATION (30014-102-94) and contains a JAR
3 100 CLOTH in 1 JAR This package is contained within a CARTON and a PACKAGE, COMBINATION (30014-102-94)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part346 07/30/2012
Labeler — McNEIL-PPC, Inc. (801375143)

Revised: 08/2012 McNEIL-PPC, Inc.

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