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X Ray Pain Relieving

Dosage form: cream
Ingredients: Menthol 10g in 100mL, Methyl Salicylate 15g in 100mL
Labeler: Genomma Lab
NDC Code: 50066-501

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.

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

  • simple backache
  • bruises
  • arthritis
  • sprains
  • strains

Warnings

For external use only


Do not use

  • on wounds or damaged, broken or irritated skin
  • with heating pad

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

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
  • excessive skin irritation occurs

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

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (MENTHOL) Menthol10 g  in 100 mL
Methyl Salicylate (SALICYLIC ACID) Methyl Salicylate15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Cetyl Alcohol 
Glycerin 
GLYCERYL MONOSTEARATE 
Isopropyl Palmitate 
Potassium Cetyl Phosphate 
Stearic Acid 
water 
Packaging
#Item CodePackage Description
1NDC:50066-501-031 TUBE in 1 CARTON
189 mL in 1 TUBE
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/FEIOperations
Product Quest Mfg.927768135manufacture(50066-501)

Revised: 02/2016
 
Genomma Lab

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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