Callus Removal Foot Pack
FDA Label NDC 69264-016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Polaroisin International Co., Ltd. for the product Callus Removal Foot Pack (NDC 69264-016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, function:, warning:, directions:, ingredients:, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Salicylic acid  11.9 mg/One pair

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:

  • 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 60-70 minutes
  • Take off the foot mask and wash away the lotion from the feet
  • Soak feet in warm water for 10 mins(everyday) 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 & 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

* Please review the disclaimer below.