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NDC 10157-2112-01 Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count) Details

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

Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count) is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc. The primary component is .

Product Information

NDC	10157-2112
Product ID	10157-2112_9c1667a8-e898-4da8-b09c-73bdbe2dcff5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)
Proprietary Name Suffix	n/a
Non-Proprietary Name	GLYCERIN, LIDOCAINE, and WITCH HAZEL
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Blistex Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10157-2112-01 (10157211201)

Pricing Information	N/A
NDC Package Code	10157-2112-1
Billing NDC	10157211201
Package	1 KIT in 1 CARTON (10157-2112-1) * 14 g in 1 TUBE * 1 mL in 1 APPLICATOR
Marketing Start Date	2019-02-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a7cb6d78-3048-43b3-afe7-4d862fdcfd3f Details

SPL UNCLASSIFIED SECTION

Tucks® Hemorrhoidal Cream

Drug Facts

SPL UNCLASSIFIED SECTION

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% w/w)

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

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 as needed but not to exceed directions for use

Inactive ingredients

citric acid, disodium EDTA, ethylhexylglycerin, glycerin, phenoxyethanol, potassium sorbate, purified water, sodium citrate

PRINCIPAL DISPLAY PANEL - Kit Carton

TUCKS®

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		14 g in 1 TUBE; Type 0: Not a Combination Product

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

Part 2 of 2
TUCKS MEDICATED COOLING witch hazel solution

Product Information
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 mL in 1 APPLICATOR; Type 0: Not a Combination Product

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

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

Labeler - Blistex Inc (005126354)

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

Revised: 12/2021

Document Id: 9c1667a8-e898-4da8-b09c-73bdbe2dcff5

Set id: a7cb6d78-3048-43b3-afe7-4d862fdcfd3f

Version: 2

Effective Time: 20211216

Search by Drug Name or NDC

NDC 10157-2112-01 Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count) Details

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

Product Information

Package

Package Images

NDC 10157-2112-01 (10157211201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a7cb6d78-3048-43b3-afe7-4d862fdcfd3f Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

When using this product

Stop use and ask a doctor if

Directions

Inactive ingredients

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL - Kit Carton

INGREDIENTS AND APPEARANCE

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