SOOTHING PAIN RELIEF  ROLL ON- menthol, unspecified form gel 
Clientele, 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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Soothing Pain Relief
Roll On

Drug Facts

Active Ingredients

Menthol 2%

Purpose

Topical analgesic

Indications

for the temporary relief of minor aches and pains of muscles and joints associated with

Warnings

  • Avoid contact with the eyes.

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a Physician.

  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

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

Directions

Inactive ingredients

Water, Butylene Glycol, Aloe Barbadensis Leaf Juice, Eucalyptus Globulus Leaf Oil, Methyl Salicylate, Camphor, Mentha Piperita (Peppermint) Oil, Silica, Potassium Citrate, Magnesium Carbonate, Oleic Acid, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.

PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label

Soothing
Pain Relief

Roll-On

2 Fl Oz (59.1 ml)

Rejuvenetics™

PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label
SOOTHING PAIN RELIEF   ROLL ON
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64483-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Camphor (synthetic) (UNII: 5TJD82A1ET) 0.52 mg  in 100 mL
Water (UNII: 059QF0KO0R)  
Eucalyptus oil (UNII: 2R04ONI662)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64483-008-0259.1 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/04/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/04/2014
Labeler - Clientele, Inc. (085021806)

Revised: 12/2019
Document Id: 1b3bb6d6-c509-4219-99e9-5e35a69fb365
Set id: f237a74d-5c5d-4c32-a7f4-af4484988c7c
Version: 1
Effective Time: 20191209
 
Clientele, Inc.