OXY RUB PAIN RELIEF- menthol cream

Oxy Rub Pain Relief by

Drug Labeling and Warnings

Oxy Rub Pain Relief by is a Otc medication manufactured, distributed, or labeled by Healthy Directions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with

• 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 imitation develops
• condition worsens or symptoms persist for more thyan 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

C13-14 Isoparaffin, Citrus Aurantium Dulcis (Orange) Oil, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glyceryl Stearate, Laureth-7, Oxidized Corn Oil, PEG-100 Stearate, Phenoxyethanol, Polycrylamide, Polysorbate-20, Water

Product Label

INGREDIENTS AND APPEARANCE

OXY RUB PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70015-645
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-7 (UNII: Z95S6G8201)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70015-645-02	57 g in 1 TUBE; Type 0: Not a Combination Product	07/30/2015
2	NDC: 70015-645-04	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 - Healthy Directions (150261183)