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  5. Label Information: Callus Removal Foot Pack

FDA Label for Callus Removal Foot Pack

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. FUNCTION
    4. WARNING
    5. DIRECTIONS
    6. INGREDIENTS
    7. PACKAGING

Callus Removal Foot Pack Product Label

The following document was submitted to the FDA by the labeler of this product Polaroisin International Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Salicylic acid 0.19%


Otc - Purpose



Remove callus


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



  • 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.
  • 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.
  • If there is any redness, swelling, itchiness, inflammation or other symptoms of the skin, please stop using it. 
  • keep out of direct sun light and high temperature. 
  • Use immediately after opening .This is the disposable merchandise. Dispose the foot packs after use.


Directions



  • Wash your feet
  • Take out the foot mask by cutting along the dotted blue line with scissor
  • Wear the foot mask and attach adhesive tape to secure the foot
  • Put the feet in the mask for about 90 minutes
  • Take off the foot mask and wash away the lotion from the feet
  • Soak feet in warm water for10 mins(every day) to accelerate peeling effects
  • 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.


* Please review the disclaimer below.