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, Accupac LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Witch Hazel (50% w/w)

Purpose

Astringent

Uses

temporarily relieves the local itching and discomfort associated with hemorrhoids
aids in protecting irritated ahorectal 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 using and ask a doctor

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

Keep out of the 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
Children under 12 years of age: ask a doctor

Other information

DO NOT FLUSH-after application, discard pad in trash and wash hands
for use as a moist compress -- if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat asbut not to exceed directions for use

Inactive ingredients

Water
Glycerin
Sodium Citrate, Unspecified form
Citric Acid Monohydrate
Ethylhexylglycerin
Phenoxyethanol
Edetate Disodium
Potassium Sorbate

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

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
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-2103-5	2 in 1 CARTON	08/30/2018
1		100 in 1 JAR
1		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 Drug	M015	08/30/2018

Labeler - Blistex Inc (005126354)

Registrant - Accupac LLC (071609663)

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