PURE-AID- camphor, menthol, methyl salicylate patch 
Kareway Product, 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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Pure-Aid Pain Relief Patch

Active ingredients

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Purpose

Topical analgesic

Uses

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

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, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

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:

Children under 12 years of age: consult a doctor

Other information

Inactive ingredients

Hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Principal Display Panel

Pure-aid Pain Relief Patch

carton

PURE-AID 
camphor, menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0289
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)21.56 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL41.73 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE69.55 mg
Inactive Ingredients
Ingredient NameStrength
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0289-11 in 1 BOX06/05/2018
110 in 1 POUCH; Type 0: Not a Combination Product
2NDC:67510-0289-21 in 1 BOX06/05/2018
220 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/05/2018
Labeler - Kareway Product, Inc. (121840057)

Revised: 6/2018
Document Id: 6def9da7-e119-fd5c-e053-2991aa0a65d2
Set id: 6def9da7-e118-fd5c-e053-2991aa0a65d2
Version: 1
Effective Time: 20180605
 
Kareway Product, Inc.