Label: CALLUS REMOVAL FOOT PACK- salicylic acid 0.19% patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69264-014-25 - Packager: POLAROISIN INTERNATIONAL CO., LTD.
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- Function
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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.
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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!
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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
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INGREDIENTS AND APPEARANCE
CALLUS REMOVAL FOOT PACK
salicylic acid 0.19% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69264-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.19 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69264-014-25 2 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358B 10/16/2014 Labeler - POLAROISIN INTERNATIONAL CO., LTD. (658727511)
