NATURELIEF (wintergreen oil- methyl salicylate, eucalyptus oil, menthol, camphor gel

Naturelief by

Drug Labeling and Warnings

Naturelief by is a Otc medication manufactured, distributed, or labeled by Novamed Healthcare Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Administration

Apply generously to affected area 3 to 4 time daily

Children under 12 consult a doctor before use.

Indication and Usage

• Back pain & Muscle Spasms result due to strain, fatigue & stress
• USES: Temporarily relieves minor aches & pains related to arthritis, headache, backache, joint and muscle pain, cramps and spasms sprains and other injuries

Inactive Ingredients

Liquid Paraffin, Sodium Lauryl Sulphate, Carbomers BP, Simulgel 600, Sodium Hydroxide

Active Ingredients

Wintergreen Oil (Methyl Salicylate) 20%

Eucalyptus Oil 3%

Menthol 2.5%

Camphor 3%

Keep out of the reach of children

Keep out of the reach of children

Stop use

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days

Purpose

Active Ingredient Purpose

Wintergreen Oil (Methyl Salicylate) 20% ...................Topical Analgesic

Eucalyptus Oil 3% ......................................................Anti-Inflammatory

Menthol 2.5% .............................................................Topical Analgesic

Camphor 3% ..............................................................Topical Analgesic

Storage

Store in a cool, dry place between 68 -77 F.

Warning

For external use only.

WHEN USING

When using this product

• Discontinue use if excessive irritation of the skin develops.
• Avoid contact with eyes and mucous membranes.
• Do not bandage.
• Do not use with a heating pad.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NATURELIEF 
wintergreen oil (methyl salicylate), eucalyptus oil, menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84859-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GAULTHERIA PROCUMBENS TOP (UNII: 830295X963) (GAULTHERIA PROCUMBENS TOP - UNII:830295X963)	GAULTHERIA PROCUMBENS TOP	5 g  in 25 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.75 g  in 25 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.75 g  in 25 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.625 g  in 25 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	0.01 g  in 25 g
CARBOMER 940 (UNII: 4Q93RCW27E)	0.355 g  in 25 g
WATER (UNII: 059QF0KO0R)	16.244 mL  in 25 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.347 g  in 25 g
PARAFFINUM LIQUIDUM (UNII: T5L8T28FGP)	0.7163 g  in 25 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84859-111-25	25 g in 1 BOX; Type 0: Not a Combination Product	12/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/16/2024

Labeler - Novamed Healthcare Private Limited (645814547)

Registrant - Novamed Healthcare Private Limited (645814547)

Establishment
Name	Address	ID/FEI	Business Operations
Novamed Healthcare Private Limited		645814547	manufacture(84859-111) , label(84859-111) , pack(84859-111)