NATRALIA CRAMP RELIEF- methyl salicylate gel

Natralia Cramp Relief by

Drug Labeling and Warnings

Natralia Cramp Relief by is a Otc medication manufactured, distributed, or labeled by Laderma Trading Pty Ltd, Jalco Pharmaceuticals Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

NATRALIA CRAMP RELIEF 
methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-3213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y)	Methyl Salicylate	105 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Benzyl Alcohol (UNII: LKG8494WBH)
Alcohol (UNII: 3K9958V90M)
Corymbia Citriodora Leaf Oil (UNII: M63U6N96EB)
Squalane (UNII: GW89575KF9)
Polysorbate 60 (UNII: CAL22UVI4M)
Lavender Oil (UNII: ZBP1YXW0H8)
Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)
Alpha-Tocopherol (UNII: H4N855PNZ1)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-3213-3	1 in 1 CARTON
1		56 g in 1 TUBE
2	NDC: 43251-3213-4	3 g in 1 PACKET

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	Business Operations
Jalco Pharmaceuticals Pty Ltd		757701409	MANUFACTURE, PACK, LABEL, ANALYSIS