CALLUS REMOVAL FOOT PACK- salicylic acid patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
POLAROISIN INTERNATIONAL CO., LTD.
INN (International Name):
SALICYLIC ACID
Composition:
SALICYLIC ACID 11.9 mg in 2
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Remove callus
Authorization status:
OTC monograph final
Authorization number:
69264-016-25

CALLUS REMOVAL FOOT PACK- salicylic acid patch

POLAROISIN INTERNATIONAL CO., LTD.

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.

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Callus Removal Foot Pack

Salicylic acid 11.9 mg/One pair

Remove callus

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

Design for convenient

Manufacturer: Polaroisin International Co.,Ltd.

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

New Taipei City 242, Taiwan.

Made In Taiwan

Packaging

CALLUS REMOVAL FOOT PACK

salicylic acid patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 26 4-0 16

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

11.9 mg in 2

Inactive Ingredients

POLAROISIN INTERNATIONAL CO., LTD.

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

LACTIC ACID, UNSPECIFIED FO RM (UNII: 33X0 4XA5AT)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

O CTO XYNO L-11 (UNII: SQL9 9 4V0 M6 )

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

SO DIUM LACTATE (UNII: TU7HW0 W0 QT)

UREA (UNII: 8 W8 T178 47W)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

GLYCERIN (UNII: PDC6 A3C0 OX)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PO LYQ UATERNIUM-10 ( 10 0 0 MPA.S AT 2 %) (UNII: GMR4PEN8 PK)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CUCUMBER (UNII: YY7C30 VXJT)

CHAMO MILE (UNII: FGL36 8 5T2X)

PELARGO NIUM GRAVEO LENS FLO WERING TO P (UNII: 1P36 QZP48 P)

HAMAMELIS VIRGINIANA TO P (UNII: UDA30 A2JJY)

LAVANDIN O IL (UNII: 9 RES347CKG)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 26 4-0 16 -25

2 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

12/17/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 F

12/17/20 15

Labeler -

POLAROISIN INT ERNAT IONAL CO., LT D. (658727511)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

POLAROISIN INTERNATIONAL CO., LTD.

6 58 727511

ma nufa c ture (6 9 26 4-0 16 )

Revised: 12/2015

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