Oxyrub Max Pain Relief Cream, 2Oz (Menthol, Methyl Salicylate) Cream [Healthy Directions, Llc] -

OXYRUB MAX PAIN RELIEF CREAM, 2OZ (MENTHOL, METHYL SALICYLATE) CREAM [HEALTHY DIRECTIONS, LLC]
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NDC	70015-650-02
Set ID	6fea637f-bf6f-455f-b3d0-416bca1b811d
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

Methol (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 developments
- 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.
INACTIVE INGREDIENT

Inactive ingredients C13-14, Insoaraffin,

Citrus Aurantium Dulcis (Organe) Oil,

Ehtylhexlglycerin, Eucalyptus Globulus Oil,

Glyceryl Stearate, Laureth-7, Oxidized Corn

Oil, PEG-100 Stearate, Phenoxyethanol,

Polyacrylamide, Polysorbate-20, Water
PRINCIPAL DISPLAY PANEL

Dr. Perigolizzi

OxyRub

MAX

Pain Relief Cream

Extra Strength

Muscle & Joint Pain Relief

Rapidly Absorbed

Deep Penetrating

Distributed by

HEALTHY DIRECTIONS

Bethesda, MD 20817

healthydirections.com

INGREDIENTS AND APPEARANCE

OXYRUB MAX PAIN RELIEF CREAM, 2OZ
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70015-650
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
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70015-650-02	1 in 1 CARTON	06/01/2017
1		57 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	06/01/2017

Labeler - Healthy Directions, LLC (150261183)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source, LLC		080354456	manufacture(70015-650)

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OXYRUB MAX PAIN RELIEF CREAM, 2OZ (MENTHOL, METHYL SALICYLATE) CREAM [HEALTHY DIRECTIONS, LLC]

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