PROFOOT PLANTAR RELIEF STRIPS (camphor- natural, menthol, methyl salicylate patch

Profoot Plantar Relief Strips by

Drug Labeling and Warnings

Profoot Plantar Relief Strips by is a Otc medication manufactured, distributed, or labeled by Profoot Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

PROFOOT PLANTAR RELIEF STRIPS 
camphor (natural), menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29784-602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	12 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	57 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	63 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29784-602-01	1 in 1 BOX	10/18/2023
1		4 in 1 POUCH
1		1.03 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/18/2023

Labeler - Profoot Inc. (107570900)