Profoot Pain Relief Patches

Profoot Pain Relief Patches

Drug Labeling and Warnings

Drug Details

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PROFOOT PAIN RELIEF PATCHES- camphor, menthol, methyl salicylate 
Profoot, Inc.

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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Profoot Pain Relief Patches

Active ingredients

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Uses For temporary relief of minor aches & pains of muscles & joints associated with:

arthritis strains bruises sprains

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

on wounds or damaged skin with a heating pad if you are allergic to any of the ingredients of

this product

When using this product

use only as directed avoid contact with the eyes, mucous membranes or rashes do not

bandage tightly

Stop use and ask a doctor if

rash, itching or excessive skin irritation develops condition worsens symptoms persist

for more than 7 days symptoms clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control

Center right away

Directions

Adults and children 12 years of age and over:

clean and dry affected area remove patch from film apply to affected area not more

than 3-4 times daily remove patch from skin after at most 8 hours

Children under 12 years of age: consult a doctor

Other information

avoid storing in direct sunlight protect product from excessive moisture

Inactive ingredients aluminum silicate, butylated hydroxytoluene, colloidal silicone dioxide,

liquid paraffin, modified gum rosin, polyisobutylene, styrene-isoprene-styrene block copolymer,

titanium dioxide, tocopherol acetate

Questions or comments? Call 1.800.526.3668 or email [email protected]

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PROFOOT PAIN RELIEF PATCHES 
camphor, menthol, methyl salicylate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 29784-600
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 29784-600-011 in 1 KIT09/26/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PATCH 0.36 g
Part 21 PATCH 1.3 g
Part 1 of 2
PROFOOT 
camphor, menthol, methyl salicylate patch
Product Information
Item Code (Source)NDC: 29784-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)12 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL57 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE63 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PARAFFIN (UNII: I9O0E3H2ZE)  
ROSIN (UNII: 88S87KL877)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
STYRENE (UNII: 44LJ2U959V)  
ISOPRENE (UNII: 0A62964IBU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 KIT
1NDC: 29784-121-360.36 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/26/2018
Part 2 of 2
PROFOOT 
camphor, menthol, methyl salicylate patch
Product Information
Item Code (Source)NDC: 29784-122
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)12 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL57 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE63 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PARAFFIN (UNII: I9O0E3H2ZE)  
ROSIN (UNII: 88S87KL877)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
STYRENE (UNII: 44LJ2U959V)  
ISOPRENE (UNII: 0A62964IBU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 KIT
1NDC: 29784-122-361.3 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/26/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/26/2018
Labeler - Profoot, Inc. (107570900)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co., Ltd.529128763manufacture(29784-600)

Revised: 12/2019
 
Profoot, Inc.


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