FOOT DETOX- zinc oxide patch 
Sichuan Fragrant Plant Biotechnology 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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Sichuan Fragrant Plant Biotechnology Co, Ltd

Active Ingredients

Zinc Oxide    8.3%

Purpose

Zinc Oxide                 Skin Protectant

Directions

Adults, and children 12 years of age and over, clean and dry up the area for the patch to be attached. Remove the protective cover sheet and gently apply. Leave it on at least 4 hours before removal. Children under 12 years of age, consult a doctor.

For adults, and children 12 years of age and over, use 1 patch daily before bed.

When Using the Product

Do not use otherwise than directed.
Do not stretch out the adhesive tape.
Do not take out the contents from the patch.
If patch is damaged, discard it right away.

Warning

For External Use Only.

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

On wounds, damaged skin or face.
If you are allergic to any ingredients of the product.
With other external product at the same time.

Stop Use and Ask a Doctor

If allergic reaction or irritation occurs.
If you are pregnant, nursing or under medical treatment.

Storage

Store in a dry and cool place away from direct sunlight.

Manufactured by

Sichuan Fragrant Plant Biotechnology Co, Ltd

Shigao Industrial Park, Tianfu New District, Xinjia Village, Shigao Town, Renshou County, Chengdu, Sichuan, China 610020

Phone: 86-28-83503710

Inactive Ingredients

FERRIC OXIDE RED, APPLE CIDER VINEGAR, SHRIMP SHELL CHITIN, SCHORL TOURMALINE, POLYETHYLENE GLYCOL 200, PANAX NOTOGINSENG ROOT, SALVIA MILTIORRHIZA ROOT, HIPPOPHAE RHAMNOIDES FRUIT, GYNOSTEMMA PENTAPHYLLUM LEAF

Drug Facts

image description

FOOT DETOX 
zinc oxide patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70837-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION8.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
SHRIMP SHELL CHITIN (UNII: 8SH93A7QWW)  
SCHORL TOURMALINE (UNII: 173O8XLY6T)  
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)  
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
GYNOSTEMMA PENTAPHYLLUM LEAF (UNII: 5DWS84R85M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70837-001-0130 in 1 BOX05/09/2016
1100 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/09/2016
Labeler - Sichuan Fragrant Plant Biotechnology Co, Ltd (544412923)
Registrant - Sichuan Fragrant Plant Biotechnology Co, Ltd (544412923)
Establishment
NameAddressID/FEIBusiness Operations
Sichuan Fragrant Plant Biotechnology Co, Ltd544412923manufacture(70837-001)

Revised: 1/2020
Document Id: 0ef21054-cb7e-42a5-93c5-c817f2de1847
Set id: 06c855f9-9de2-4844-a726-73169a4724e9
Version: 32589
Effective Time: 20200117
 
Sichuan Fragrant Plant Biotechnology Co, Ltd