OXYRUB PRO PAIN RELIEF CREAM, 4OZ- menthol, methyl salicylate cream

OxyRub Pro Pain Relief by

Drug Labeling and Warnings

OxyRub Pro Pain Relief by is a Otc medication manufactured, distributed, or labeled by Healthy Directions, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active Ingredients 

Menthol (2.5%)

Methyl Salicylate (10%)

PURPOSE

Purpose

Topical Analgesic 

INDICATIONS & USAGE

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: 

• simple backaches 
• arthritis 
• strains 
• sprains 
• bruises

WARNINGS

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. 

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information 

Store at room termperature. For Lot Number and Expiration Date, see bottom of the carton or crimp at end of tube. 

INACTIVE INGREDIENT

Inactive ingredients C13-14 Isoparaffin,

Citrus Aurantium Dulcis (Orange) Oil,

Ethylhexylglycerin, Eucalyptus Globulus Oil,

Glyceryl Stearate, Laureth-7, Oxidized Corn

Oil, PEG-100 Stearate, Phenoxyethanol,

Polyacrylamide, Polysorbate-20, Water 

PRINCIPAL DISPLAY PANEL

Dr. Pergolizzi 

OxyRub 

PRO

Pain Relief Cream

PROFESSIONAL STRENGTH 

MUSCLE & JOINT

PAIN RELIEF 

RAPIDLY

ABSORBED 

DEEP

PENETRATING 

Net Wt. 4 oz (114 g)

Distributed by 

HEALTHY DIRECTIONS 

6710A Rockledge Drive, Suite 500 

Bethesda, MD 20817

INGREDIENTS AND APPEARANCE

OXYRUB PRO PAIN RELIEF  CREAM, 4OZ
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70015-655
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	25.0 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ORANGE OIL (UNII: AKN3KSD11B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-7 (UNII: Z95S6G8201)
CORN OIL (UNII: 8470G57WFM)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70015-655-04	1 in 1 CARTON	09/01/2017
1		114 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2017

Labeler - Healthy Directions, LLC (150261183)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(70015-655)