PAIN RELIVING ROLL-ON- menthol gel 
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 Relievng Gel Roll-On

Drug Facts

Active ingredient

Menthol 4%

Purpose

Pain Relieving Gel

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

When using this product

  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

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

Other information

Inactive ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis (Green Tea) Leaf Extract, Camphor, Carbomer, Centella Asiatica Extract, Ethylhexylglycerin, FD&C Blue No.1, FD&C Yellow No.5, IIex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Phenoxyethanol, Propylene Glycol, Tocopheryl Acetate, Trolamine, Water

Exclusively distributed by:

Kareway Product, Inc.

Compton, CA 90220

www.kareway.com

PRINCIPAL DISPLAY PANEL

label

PAIN RELIVING ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0673
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CAMPHOR OIL (UNII: 75IZZ8Y727)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0673-274 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/24/2023
Labeler - KAREWAY PRODUCT, INC. (121840057)

Revised: 1/2023
Document Id: f3093a16-5ed9-19eb-e053-2995a90a22bc
Set id: f3093a16-5ed8-19eb-e053-2995a90a22bc
Version: 1
Effective Time: 20230124
 
KAREWAY PRODUCT, INC.