OXYRUB PAIN RELIEF- menthol cream

OxyRub Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

OXYRUB PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BITTER ORANGE OIL (UNII: 9TLV70SV6I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
LAURETH-7 (UNII: Z95S6G8201)
CORN OIL (UNII: 8470G57WFM)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-113-04	114 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2013

Labeler - Pure Source, LLC (080354456)

Registrant - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-113)