PROFOOT PAIN RELIEF PATCHES- camphor, menthol, methyl salicylate kit

Profoot Pain Relief Patches by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%

PURPOSE

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

INDICATIONS & USAGE

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

arthritis strains bruises sprains

WARNINGS

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

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

Center right away

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

avoid storing in direct sunlight protect product from excessive moisture

INACTIVE INGREDIENT

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

Questions or comments? Call 1.800.526.3668 or email service@profoot.co

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROFOOT PAIN RELIEF PATCHES 
camphor, menthol, methyl salicylate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29784-600

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29784-600-01	1 in 1 KIT	09/26/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PATCH	0.36 g
Part 2	1 PATCH	1.3 g

Part 1 of 2

PROFOOT 
camphor, menthol, methyl salicylate patch

Product Information
Item Code (Source)	NDC: 29784-121
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 KIT
1	NDC: 29784-121-36	0.36 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 not final	part348	09/26/2018

Part 2 of 2

PROFOOT 
camphor, menthol, methyl salicylate patch

Product Information
Item Code (Source)	NDC: 29784-122
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 KIT
1	NDC: 29784-122-36	1.3 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 not final	part348	09/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/26/2018

Labeler - Profoot, Inc. (107570900)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.		529128763	manufacture(29784-600)