X RAY PAIN RELIEVING- menthol - 10.00% methyl salicylate - 15.00% cream 
Genomma Lab

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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Drug Facts

Active ingredients                              Purpose

Menthol-10% .................................... Topical Analgesic
Methyl Salicylate -15% .....................Topical Analgesic

Uses

Temporary relief of minor aches and pains of muscles

and joints associated with

Warnings

For external use only


Do not use

When using this product

Stop use and ask a doctor if

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

Directions

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age: Consult a doctor.

Aminomethyl Propanol,Carbomer,Cetyl Alcohol,Glycerin,Glyceryl Stearate,Isopropyl Palmitate,Potassium Cetyl Phosphate,Stearic Acid,Water

image description

X RAY PAIN RELIEVING 
menthol - 10.00% methyl salicylate - 15.00% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol10 g  in 100 mL
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Glycerin (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
Stearic Acid (UNII: 4ELV7Z65AP)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-501-031 in 1 CARTON12/15/2015
189 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/15/2015
Labeler - Genomma Lab (832323534)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(50066-501)

Revised: 4/2018
Document Id: 07a9b5fe-40b1-4805-8138-5250b531e885
Set id: 895f3cc0-719b-4553-a49e-021ceee65a7d
Version: 2
Effective Time: 20180405
 
Genomma Lab