Oxyrub Pro Pain Relief Cream, 4Oz (Menthol, Methyl Salicylate) Cream [Healthy Directions, Llc] -

OXYRUB PRO PAIN RELIEF CREAM, 4OZ (MENTHOL, METHYL SALICYLATE) CREAM [HEALTHY DIRECTIONS, LLC]
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NDC	70015-655-04
Set ID	be26909d-afbb-4b89-a64a-fd130de223c7
Category	HUMAN OTC DRUG LABEL
Packager	Healthy Directions, LLC
Generic Name
Product Class
Product Number
Application Number	PART348

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/01/2017

Labeler - Healthy Directions, LLC (150261183)

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

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OXYRUB PRO PAIN RELIEF CREAM, 4OZ (MENTHOL, METHYL SALICYLATE) CREAM [HEALTHY DIRECTIONS, LLC]

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