SMARTRX NATURAL PAIN RELIEF SLEEVE ANKLE- methyl salicylate liquid 
Niche Brands, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SmartRx Natural Pain Relief Sleeve ANKLE

SmartRx Natural Pain Relief Sleeve ANKLE


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.

Other information:

Allergy warning:

Contains Macadamia nut oil.

Inactive ingredients

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

Questions?:

000-000-0000

SmartRx Natural Pain Relief Sleeve ANKLE 1 count (60589-001-00)

Ankle Sleeve

SMARTRX NATURAL PAIN RELIEF SLEEVE ANKLE 
methyl salicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60589-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MACADAMIA OIL (UNII: 515610SU8C)  
CITRONELLA OIL (UNII: QYO8Q067D0)  
MANDARIN OIL (UNII: NJO720F72R)  
CORIANDER OIL (UNII: 7626GC95E5)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60589-001-001 in 1 BOX
10.2 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/27/2013
Labeler - Niche Brands, Inc. (079208100)
Establishment
NameAddressID/FEIBusiness Operations
AB7 Industries381206077manufacture(60589-001)

Revised: 12/2013
Document Id: 09d74dce-91c6-4283-abcb-839e27431007
Set id: 9f17d8ef-1a59-4ad7-800e-9bc8d223ccdb
Version: 1
Effective Time: 20131227
 
Niche Brands, Inc.