ASSURED MUSCLE RUB- menthol gel 
Greenbrier International, 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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Assured™ Muscle Rub

Drug Facts

Active ingredient

Menthol 2.5%

Purpose

Topical Analgesic

Use

Temporarily relieves the minor aches and pains in muscles and joints associated with:

Warnings

For external use only.

Avoid contact with the eyes or on mucous membranes.

Do not use

  • on wounds or damaged skin

Stop use if

  • excessive irritation develops

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

When using this product

  • do not bandage or wrap tightly

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: 800-222-1222.

Directions

Other information

Inactive ingredients

Camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, purified water, sodium hydroxide

Questions or comments?

866-323-0107 or www.natureplex.com

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton

ASSURED

EXTRA STRENGTH PAIN RELIEVING GEL

Muscle Rub

Menthol 2.5%

Fast relief from:

NET WT 1.5 OZ (42.5 g)

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton
ASSURED  MUSCLE RUB
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1136
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1136-142.5 g in 1 TUBE; Type 0: Not a Combination Product05/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/15/2012
Labeler - Greenbrier International, Inc. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(33992-1136)

Revised: 12/2017
Document Id: d85735b7-7a77-42df-8fb1-9fefb8aaa791
Set id: 81317756-e678-40fa-95ea-a9d7ecd98481
Version: 3
Effective Time: 20171228
 
Greenbrier International, Inc.