SMARTRX NATURAL PAIN RELIEF SLEEVE BACK- methyl salicylate liquid

SmartRx Natural Pain Relief Sleeve BACK by

Drug Labeling and Warnings

SmartRx Natural Pain Relief Sleeve BACK by is a Otc medication manufactured, distributed, or labeled by Niche Brands, Inc., AB7 Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SmartRx Natural Pain Relief Sleeve BACK

Active ingredient

Methyl Salicylate 10%

Purpose

External Analgesic (Counterirritant)

Use

for the temporary relief of minor aches and pains of muscles and joints associated with arthritis strains bruises sprains.

Warnings

For external use only. Avoid contact with the eyes.

When using this product

• Do not use otherwise than as directed.
• Do not apply to wounds or damaged skin.
• Do not bandage tightly.
• Do not use in conjunction with liniments, balms or lotions.
• Do not use on damaged or broken skin.
  

Stop use and ask a doctor if

• Redness is present.
• Excessive irritation of skin develops.
• Condition worsens, or if symptoms persist for more than 7 days.
  

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

if swallowed, get medical help or contact Poison Control Center right away.

Directions

Open pouch and remove. Pull woven sleeve containing external analgesic pads over ankle, positioning on either side of affected area.

• Adults and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
• Children under 3 years of age: Consult a physician.
  

Other information:

• Store away from direct sunlight.
• For your protection, this sleeve has been sealed in an aluminum pouch.
• Do not use if tamper evident seal is missing, tampered, broken or destroyed.
  

Allergy warning:

Contains Macadamia nut oil.

Inactive ingredients

Macadamia nut oil, citronella oil, mandarin oil, coriander oil and rosemary oil.

Questions?:

000-000-0000

Product Lable

INGREDIENTS AND APPEARANCE

SMARTRX NATURAL PAIN RELIEF SLEEVE BACK 
methyl salicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60589-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MACADAMIA OIL (UNII: 515610SU8C)
CITRONELLA OIL (UNII: QYO8Q067D0)
MANDARIN OIL (UNII: NJO720F72R)
CORIANDER OIL (UNII: 7626GC95E5)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60589-002-00	1 in 1 BOX
1		0.2 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/27/2013

Labeler - Niche Brands, Inc. (079208100)

Establishment
Name	Address	ID/FEI	Business Operations
AB7 Industries		381206077	manufacture(60589-002)