OxyRub Pain Relief

Dosage form: cream
Ingredients: MENTHOL 1.25g in 100g
Labeler: Pure Source Inc.
NDC Code: 65121-113

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.

OxyRub Pain Relief Cream

OxyRub Pain Relief Cream

Active Ingredient

Menthol (1.25%)

Purpose

Topical Analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated

  • simple backaches
  • arthritis
  • strains
  • sprains 
  • bruises

Warnings

For external use only.

  • Use only as directed.

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin

Ask a doctor before use if you have redness over the affected area

When using this product

  • Avoid contact with eyes
  • Do not bandage tightly

Stop use and consult a doctor if

  • skin redness or excessive skin irritation develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again in a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older. Apply to affected area no more than 3-4 times daily.
Children under 12 years of age, consult a doctor.

Other information

Store at room temperature. For Lot Number and Expiration Date, see crimp at end of tube.

Inactive Ingredients

Bitter Orange Oil, C13-14 Isoparaffin, Caprylhydroxomic Acid, Caprylyl Glycol, Eucalyptus Oil, Glycerin, Laureth-7, Oxidized Corn Oil, Polyacrylamide (1000 MW), Polysorbate 20, Water

OxyRub Pain Relief Cream 4oz/114g (65121-113-04)

OXYRUB PAIN RELIEF  
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-113
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BITTER ORANGE OIL 
C13-14 ISOPARAFFIN 
CAPRYLHYDROXAMIC ACID 
CAPRYLYL GLYCOL 
EUCALYPTUS OIL 
GLYCERIN 
LAURETH-7 
CORN OIL 
POLYSORBATE 20 
WATER 
Packaging
#Item CodePackage Description
1NDC:65121-113-04114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2013
Labeler - Pure Source Inc. (969241041)
Registrant - Pure Source Inc. (969241041)
Establishment
NameAddressID/FEIOperations
Pure Source Inc.969241041manufacture(65121-113)

Revised: 05/2013
 
Pure Source Inc.

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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