Label: CALLUS REMOVAL FOOT PACK- salicylic acid 0.19% patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 16, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Salicylic acid 0.19%

  • PURPOSE

    Remove callus

  • KEEP OUT OF REACH OF CHILDREN

    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 in to the dead skin cells and separate the dead skin from the healthy skin to reveal smooth feet

  • Warning

    1. Callus Removal Foot Pack is not suitable for patients with Glucose -6-Phosphate Dehydrogenase deficiency (G6PD), pregnant woman, Reye's syndrome, patients intolerant to salicylate or diabetic patients.
    2. Avoid prolonged and excessive use on large area of body or on broken or inflamed skin. Avoid contact with eyes, mouth or other mucous membrane.
    3. If there is any redness, swelling, itchiness, inflammation or other symptoms of the skin, please stop using it. 
    4. keep out of direct sun light and high temperature. 
    5. Use immediately after opening .This is the disposable merchandise. Dispose the foot packs after use.

  • 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 90 minutes
    5. Take off the foot mask and wash away the lotion from the feet
    6. Soak feet in warm water for10 mins(every day) 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, GLYCOLIC ACID, ISOPROPYL ALCOHOL, LACTIC ACID, SODIUM LACTATE, GLYCERIN, PROPYLENE GLYCOL,1.3 BUTYLENE GLYCOL, CITRIC ACID, SODIUM CITRATE, XANTHAN GUM,COLLAGEN, SODIUM HYALURONATE, DIPOTASSIUM GLYCYRRHIZATE,MANDELIC ACID, GLYCOSYL TREHALOSE, ALOE BARBADENSIS LEAF EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, METHYL GLUCETH-20, POLYSORBATE 20, UREA, SODIUM PCA, PHENOXY ETHANOL.

  • Packaging

    Callus Removal Foot Pack

  • INGREDIENTS AND APPEARANCE
    CALLUS REMOVAL FOOT PACK 
    salicylic acid 0.19% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69264-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.19 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID (UNII: 33X04XA5AT)  
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COLLAGEN ALPHA-1(III) (HUMAN) (UNII: 5D8UAE62VB)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    MANDELIC ACID (UNII: NH496X0UJX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    UREA (UNII: 8W8T17847W)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TREHALOSE (UNII: B8WCK70T7I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69264-014-252 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B10/16/2014
    Labeler - POLAROISIN INTERNATIONAL CO., LTD. (658727511)