CALLUS REMOVAL FOOT PACK- salicylic acid patch

Callus Removal Foot Pack by

Drug Labeling and Warnings

Callus Removal Foot Pack by is a Otc medication manufactured, distributed, or labeled by POLAROISIN INTERNATIONAL CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic acid  11.9 mg/One pair

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 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:

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

SPL UNCLASSIFIED SECTION

Design for convenient

Manufacturer: Polaroisin International Co.,Ltd.

10F., No.173, Siyuan Rd., Xinzhuang District,

New Taipei City 242, Taiwan.

Made In Taiwan

Packaging

INGREDIENTS AND APPEARANCE

CALLUS REMOVAL FOOT PACK 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69264-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	11.9 mg  in 2

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
ALCOHOL (UNII: 3K9958V90M)
OCTOXYNOL-11 (UNII: SQL994V0M6)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM LACTATE (UNII: TU7HW0W0QT)
UREA (UNII: 8W8T17847W)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
CHAMOMILE (UNII: FGL3685T2X)
PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
LAVANDIN OIL (UNII: 9RES347CKG)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69264-016-25	2 in 1 BAG; Type 0: Not a Combination Product	12/17/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358F	12/17/2015

Labeler - POLAROISIN INTERNATIONAL CO., LTD. (658727511)

Establishment
Name	Address	ID/FEI	Business Operations
POLAROISIN INTERNATIONAL CO., LTD.		658727511	manufacture(69264-016)