TUCKS MEDICATED COOLING PADS- witch hazel solution

Tucks Medicated Cooling Pads by

Drug Labeling and Warnings

Tucks Medicated Cooling Pads by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Witch hazel 50%

Purpose

Astringent

Uses

• temporarily relieves the local itching and discomfort associated with hemorrhoids
• aids in protecting irritated anorectal areas
• temporarily relieves irritation 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 directly in 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, clean 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 area up to 6 times daily or after each bowel movement
• after application, discard pad and wash hands

Children under 12 years of age: ask a doctor

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - 100 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

BRAND USED BY HOSPITALS®

100 PADS

INGREDIENTS AND APPEARANCE

TUCKS MEDICATED COOLING PADS 
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-2103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	500 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-2103-2	1 in 1 CARTON	08/30/2016
1		100 in 1 JAR
1		1 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 10157-2103-1	1 in 1 CARTON	08/30/2016
2		40 in 1 JAR
2		1 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 10157-2103-3	40 in 1 JAR	08/30/2016
3		1 mL in 1 APPLICATOR; Type 0: Not a Combination Product
4	NDC: 10157-2103-4	2 in 1 CARTON	08/30/2016
4		100 in 1 JAR
4		1 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	08/30/2016

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	manufacture(10157-2103)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		071609663	manufacture(10157-2103)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		829295349	manufacture(10157-2103)