SHOPKO MEDICATED COOLING- witch hazel swab 
Shopko Stores Operating Co., LLC.

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.

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SHOPKO Medicated Cooling Pads

Active Ingredient

Witch hazel 50%

Purpose

Astringent

Uses

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

If pregnant or breast-feeding

Ask a health professional before use

Directions

Other information

Inactive Ingredients

Alcohol, Aloe, citric acid, Decyl Glucoside, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water.

Principal Display Panel

SHOPKO

Compared to the active ingredients in Tucks*

Medicated Cooling Pads

hemorrhoidal pads with witch hazel

100 pads 3.0 sq. in. (7.6 sq. cm)


Label


SHOPKO MEDICATED COOLING 
witch hazel swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-211-00100 in 1 PACKAGE05/09/2017
12.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/09/2017
Labeler - Shopko Stores Operating Co., LLC. (023252638)
Registrant - Shopko Stores Operating Co., LLC. (023252638)
Establishment
NameAddressID/FEIBusiness Operations
PREMIER CARE INDUSTRIES, INC858442403manufacture(37012-211)

Revised: 2/2019
Document Id: b45381b4-c0a6-4a92-bf9d-6e87c7f21a85
Set id: 48511614-727d-41cb-81cc-3d2baf61b8b6
Version: 2
Effective Time: 20190201
 
Shopko Stores Operating Co., LLC.