PROFOOT PLANTAR RELIEF STRIPS- camphor (natural), menthol, methyl salicylate patch 
Profoot Inc.

----------

Profoot Plantar Relief Strips

Drug Facts

Active ingredients

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%

Purpose

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 ingredients of this product

When using this product

• use only as directed • avoid contact with the eyes, mucocus membranes or rashes • do not bandage tightly

Stop use and ask a doctor if

• rash, itching or excessive skin irritation develops • condtions worsen • symtomps persist for more than 7 days • symptoms clean up and occur again within a few days

If pregnant or reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

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 • hold patch wide end up to make a "I" shape • only peel off film on wide end first, stopping halfway • apply patch so that wings wrap around arch •remove remaing film & pull back to wrap around heel • 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

hydrogenated poly, pentaerythrityl tetra-di-t-butyl Hydroxyhydrocinnamate, white mineral oil, styrene/Isoprene copolymer

Questions or comments?

Email cservice@profoot.co

Package Labeling:

Profoot labelLabel

PROFOOT PLANTAR RELIEF STRIPS 
camphor (natural), menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29784-602
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
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29784-602-011 in 1 BOX10/18/2023
14 in 1 POUCH
11.03 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/18/2023
Labeler - Profoot Inc. (107570900)

Revised: 10/2023
Document Id: 08195e48-e02b-8011-e063-6394a90aae6b
Set id: 65e142d8-da21-4c55-9faf-b387cb6c2c0e
Version: 1
Effective Time: 20231019
 
Profoot Inc.