MUSCLE RUB- muscle rub cream 
MEDZONE PRODUCTS LLC

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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Muscle Rub

Active Ingredient

Active IngredientUse
Menthol 3.5%Topical Analgesic

Uses

Uses:

Do Not Use

Do not use:

Stop use and ask a physicinan if:

Stop use and ask a physician if:

Directions

Directions
Use only as directed
Adults and children 12 years of age and older, rub a thin layer to affected area 3-4 times daily
Children under 12 years of age consult a physician
Wash hands after applying

Storage

Store at 68-86 degrees with lid tightly closed

Inactive Ingredient

Alcohol Denaturated, Camphor, Carbomer, Ethylhexylglycerin, Glycerin, Jaanese Green tea ( Camellia Sinesis) Extract, Laureth-4, Petrolatum, Pineapple (Ananas Sativus) Extract, Polysorbate 80, Propylene Glycol, Phenoxyethanol, Triethanolamine, Water

Warnings For External Use Only:


Warnings For External Use Only:

Distributed By

Distributed by: MedZone

Lenexa, Kansas

Ph 913-948-9663

www.medzonecorp.com

Muscle Rub

MUSCLE RUB 
muscle rub cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-652
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
LAURETH-4 (UNII: 6HQ855798J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70338-652-0185 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2019
Labeler - MEDZONE PRODUCTS LLC (080083739)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Pharmaceuticals Laboratories LLC116933772manufacture(70338-652)

Revised: 12/2020
Document Id: b76a758b-4dbd-961b-e053-2995a90ab04c
Set id: 9b0c5de3-cfff-23db-e053-2995a90a27b4
Version: 2
Effective Time: 20201226
 
MEDZONE PRODUCTS LLC