SALICYLIC ACID- medicated callus removers extra thick patch 
Chain Drug Consortium, 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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Premier Value Extra Thick Callus Removers

​Active ingredient

Salicylic acid 40%

Purpose

Callus remover

Use

Warnings

For external use only.

Do not use

  • if you are a diabetic
  • if you have poor blood circulation
  • on irritated skin, on any area that is infected or reddened

​Stop use and ask a doctor

if discomfort persists

​Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

store between 15°C to 30°C (59°F to 86°F)

Inactive ingredients

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Questions?

call 1-866-964-0939

Principal Display Panel

Premier Value

Extra Thick
CALLUS REMOVERS

Salicylic acid

4 MEDICATED PATCHES/4 PADS

Premier Value_Extra Thick Callus Removers_LFCLRETPV.jpg

SALICYLIC ACID 
medicated callus removers extra thick patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID40 mg  in 4 
Inactive Ingredients
Ingredient NameStrength
POLYVINYL ALCOHOL (UNII: 532B59J990)  
VINYL ACETATE (UNII: L9MK238N77)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-230-044 in 1 PACKAGE; Type 0: Not a Combination Product02/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358F02/12/2018
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Premier Brands of America (063849780)
Establishment
NameAddressID/FEIBusiness Operations
Premier Brands of America080051232relabel(68016-230) , repack(68016-230)
Establishment
NameAddressID/FEIBusiness Operations
Alchemix Corporation615263956manufacture(68016-230)

Revised: 12/2019
Document Id: 489e1114-2f04-4f8d-b4d1-7b25022a587e
Set id: f9939024-fdcb-42bd-9f25-b5bafa79a876
Version: 2
Effective Time: 20191212
 
Chain Drug Consortium, LLC