Callus Removal Foot Pack
FDA Label NDC 69264-014

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 69264-014). 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, otc - purpose, function, warning, directions, ingredients, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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