RELEXO OIL- menthol, camphor oil
InvaTech Pharma Solutions LLC

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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RELEXO MASSAGE OIL

Relexo Massage oil

Active Ingredients

Menthol 10%

Camphor 5%

Purpose

Natural support for healthy joints

Uses

Temporary relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Inactive Ingredients

Mustard oil, Linseed oil, Wintergreen oil, Ajowa oil, Boswelia oil, Mustard oil processed with Castor, Drum stick, Thorn apple, Cissus quandragularis

Direction for use

Gently massage the oil over the affected body parts or as directed by physician.

Warnings

Do not apply on an open wound or to exposed skin
If you are pregnant or breast-feeding, consult your healthcare professional before use
If condition gets worse or skin irritation occurs, stop usage and consult your doctor

Keep out of children's reach

Other Information

Apply on samll area of skin to test any allergic reactions before using.

(*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.)

BAPS AMRUT
Relexo Massage oil

image description

RELEXO OIL
menthol, camphor oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57631-116
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 in 1 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	2.5 in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MUSTARD OIL (UNII: TYY1MA9BSY)
LINSEED OIL (UNII: 84XB4DV00W)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
CISSUS QUADRANGULARIS WHOLE (UNII: 3VMW64U790)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57631-116-11	1 in 1 CARTON	06/14/2017
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/28/2017

Labeler - InvaTech Pharma Solutions LLC (078602180)

Registrant - InvaTech Pharma Solutions LLC (078602180)

Name	Address	ID/FEI	Business Operations
Establishment
InvaTech Pharma Solutions LLC		078602180	relabel(57631-116)

Name	Address	ID/FEI	Business Operations
Establishment
BAPS Swaminarayan Herbal Care,A Unit of Divine Energy		921183294	manufacture(57631-116) , analysis(57631-116) , pack(57631-116)