TUCKS MULTI-CARE RELIEF KIT (TUCKS HEMORRHOIDAL AND TUCKS MEDICATED COOLING 40 COUNT)- glycerin, lidocaine, and witch hazel kit

Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count) by

Drug Labeling and Warnings

Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count) by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Tucks® Hemorrhoidal Cream

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Glycerin 15.0% (w/w)	Protectant
Lidocaine 5.0% (w/w)	Local anesthetic

Uses

• temporarily relieves the local pain, itching and discomfort associated with hemorrhoids
• temporarily provides a coating for relief of anorectal discomforts
• temporarily relieves rectal irritation and burning

Warnings

For external use only

When using this product

• do not exceed the recommended daily dosage unless directed 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
• certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

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

Children under 12 years of age: ask a doctor

Inactive ingredients

arachidyl alcohol, arachidyl glucoside, avena sativa kernel flour (colloidal oatmeal), behenyl alcohol, disodium EDTA, ethylhexylglycerin, microcrystalline wax, petrolatum, phenoxyethanol, polyglyceryl-3 diisostearate, polysorbate 60, purified water, sorbitan isostearate, stearyl behenate

SPL UNCLASSIFIED SECTION

Tucks® Medicated Cooling Pads

Drug Facts

Active ingredient

Witch hazel (50% v/v)

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

Other information

• 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 as needed but not to exceed directions for use

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - Kit Carton

TUCKS®

New

MULTI-CARE
RELIEF KIT

Cream: Local Anesthetic / Protectant
Pads: Astringent

Lidocaine 5% Cream
to numb & protect
painful hemorrhoids
+
Witch Hazel Pads
to cleanse & soothe
rectal or vaginal areas

TUCKS®
HEMORRHOIDAL CREAM
MAXIMUM STRENGTH LIDOCAINE

with
Colloidal
Oatmeal

TUCKS®
MEDICATED COOLING PADS
WITH WITCH HAZEL
40 PADS

with
Ultra-soft
Fabric

Net Wt. 0.5 oz.
(14 g) - 1 Tube

2-Product Value

40 Pads
1 Jar

INGREDIENTS AND APPEARANCE

TUCKS MULTI-CARE RELIEF KIT (TUCKS HEMORRHOIDAL AND TUCKS MEDICATED COOLING 40 COUNT) 
glycerin, lidocaine, and witch hazel kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-2112

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-2112-1	1 in 1 CARTON	02/15/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	14 g
Part 2	1 APPLICATOR	1 mL

Part 1 of 2

TUCKS HEMORRHOIDAL 
glycerin, and lidocaine cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	15 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARYL BEHENATE (UNII: A68S9UI39D)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
OATMEAL (UNII: 8PI54V663Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		14 g in 1 TUBE; 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	02/15/2019

Part 2 of 2

TUCKS MEDICATED COOLING 
witch hazel solution

Product Information
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		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	02/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	02/15/2019

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-2112)