CALLUS REMOVAL FOOT PACK- salicylic acid patch 
POLAROISIN INTERNATIONAL CO., LTD.

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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Callus Removal Foot Pack

Salicylic acid  11.9 mg/One pair

Remove callus

Keep out of reach of children

Function:

BRAPHY 7 days Callus Removal Foot Pack is the gentle solution to remove callus. Formulated with several natural fruit acids, it can penetrate into the dead skin cells and separate the dead skin from the healthy skin to reveal smooth feet

Warning:

Take out a little essence after cutting a tiny hole of the callus removal foot pack and smear on an area of foot for testing its reaction before using the mask. Wait around 60 minutes, then wash away lotion and dry your foot. If there is any redness, swelling, itching, inflammation or other uncomfortable symptoms, please refer to your doctor before using it.

Directions:

  1. Wash your feet
  2. Take out the foot mask by cutting along the dotted blue line with scissor
  3. Wear the foot mask and attach adhesive tape to secure the foot
  4. Put the feet in the mask for about 60-70 minutes
  5. Take off the foot mask and wash away the lotion from the feet
  6. Soak feet in warm water for 10 mins(everyday) to accelerate peeling effects
  7. Callus will start exfoliating after 3 days (no rubbing, it will peel off automatically). After 1 week, all calluses will be removed!

Ingredients:

PURE WATER & ISOPROPYL ALCOHOL & LACTIC ACID & ALCOHOL & OCTOXYNOL-11/POLYSORBATE 20 & SODIUM LACTATE & UREA & SODIUM CITRATE & GLYCERIN & CITRIC ACID & POLYQUATERNIUM-10 & SALICYLIC ACID & ALOE BARBADENSIS LEAF JUICE & CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT & CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT & PELARGONIUM GRAVEOLENS EXTRACT & HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT & LAVANDULA HYBRIDA OIL & POTASSIUM HYDROXIDE

Design for convenient

Manufacturer: Polaroisin International Co.,Ltd.

10F., No.173, Siyuan Rd., Xinzhuang District,

New Taipei City 242, Taiwan.

Made In Taiwan

Packaging

Callus removal

CALLUS REMOVAL FOOT PACK 
salicylic acid patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69264-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID11.9 mg  in 2 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ALCOHOL (UNII: 3K9958V90M)  
OCTOXYNOL-11 (UNII: SQL994V0M6)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
UREA (UNII: 8W8T17847W)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CUCUMBER (UNII: YY7C30VXJT)  
CHAMOMILE (UNII: FGL3685T2X)  
PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
LAVANDIN OIL (UNII: 9RES347CKG)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69264-016-252 in 1 BAG; Type 0: Not a Combination Product12/17/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358F12/17/2015
Labeler - POLAROISIN INTERNATIONAL CO., LTD. (658727511)
Establishment
NameAddressID/FEIBusiness Operations
POLAROISIN INTERNATIONAL CO., LTD.658727511manufacture(69264-016)

Revised: 12/2015
Document Id: eee53321-ca57-416f-8c1e-36f205a387a7
Set id: 883d2910-084b-4a80-b30e-e7bdff8087ce
Version: 1
Effective Time: 20151217
 
POLAROISIN INTERNATIONAL CO., LTD.