COLD AND HOT PAIN RELIEF SLEEVE- menthol 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 Cold & Hot Sleeve

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with arthritis, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

Warnings

For external use only

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

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 over 12 years

Children 12 years or younger:

Inactive ingredients

Glycerin, Hydroxyethylcellulose, Isopropyl Alcohol, Polysorbate 80, Methylparaben, Propylparaben, Purified Water

Package label

image of carton label
COLD AND HOT PAIN RELIEF SLEEVE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0085-41 in 1 BOX04/19/2012
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/19/2012
Labeler - Kareway Product, Inc. (121840057)

Revised: 9/2020
Document Id: ae81ade6-5e4b-bc6a-e053-2a95a90a8332
Set id: 1a11d455-c8e5-4ee7-8e0b-6c3eefc29c86
Version: 2
Effective Time: 20200904
 
Kareway Product, Inc.