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Name:Natralia Cramp Relief
Manufacturer:Laderma Trading Pty Ltd
Category:Over-the-counter (OTC) Marketed Drugs


natralia™ NATURALLY AUSTRALIAN muscle cramp relief gel

NATRALIA CRAMP RELIEF - methyl salicylate gel 
Laderma Trading Pty Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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natralia™
NATURALLY AUSTRALIAN
muscle cramp
relief gel

Drug Facts

Active ingredient

Methyl Salicylate 10.5%

Purpose

Pain Relieving

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

  • For External Use Only
     
  • Avoid contact with eyes
     
  • Do not apply to wounds or damaged skin
     
  • Do not bandage tightly
     
  • Do not use other than as directed

  • Keep out of reach of children to avoid accidental poisoning
     
  • If swallowed, seek medical help or contact a Poison Control Center right away

  • If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within few days, discontinue use of this product and consult a physician.

  • Do not use if tube seal is broken or appears tampered with.

Directions

  • Adults and children 2 years of age and older: apply to affected area not more than 3 - 4 times daily.
  • Children under 2 years of age: consult a physician.

Other information

  • Store between 50° – 86°F in a dry place

Inactive ingredients

Benzyl Alcohol, Ethanol, Eucalyptus Globulus Leaf Oil, Hydroxyethyl Acrylate/Sodium Acryloyldimethyltaurate Copolymer (and) Squalane (and) Polysorbate 60, Lavandula Angustifolia (Lavender) Oil, PEG-40 Hydrogenated Castor Oil, Tocopherol, Water.

Questions or comments?

Call Toll Free 1-877-687-2542

usainfo@natralia.com.au

www.natralia.com.au/usa

PRINCIPAL DISPLAY PANEL - 56g Tube Carton

natralia™
NATURALLY AUSTRALIAN

muscle cramp
relief gel

natural alternative

FAST
ACTING

Topical Analgesic

A natural alternative
for the temporary
relief of:

  • Minor Aches
  • Muscle Pain
  • Joint Pain

Net Wt 2 oz (56g)

PRINCIPAL DISPLAY PANEL - 56g Tube Carton

NATRALIA CRAMP RELIEF 
methyl salicylate gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43251-3213
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methyl Salicylate (Methyl Salicylate) Methyl Salicylate 105 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol  
Alcohol  
Corymbia Citriodora Leaf Oil  
Squalane  
Polysorbate 60  
Lavender Oil  
Polyoxyl 40 Hydrogenated Castor Oil  
Alpha-Tocopherol  
Water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43251-3213-3 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 56 g in 1 TUBE This package is contained within the CARTON (43251-3213-3)
2 NDC:43251-3213-4 3 g in 1 PACKET None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/01/2009

Labeler - Laderma Trading Pty Ltd (758651624)
Establishment
Name Address ID/FEI Operations
Jalco Pharmaceuticals Pty Ltd 757701409 MANUFACTURE, PACK, LABEL, ANALYSIS

Revised: 01/2011 Laderma Trading Pty Ltd



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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