AMRUT BALM- menthol, camphor ointment

Amrut Balm by

Drug Labeling and Warnings

Amrut Balm by is a Otc medication manufactured, distributed, or labeled by InvaTech Pharma Solutions LLC, BAPS Swaminarayan Herbal Care,A Unit of Divine Energy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BAPS AMRUT BALM Active Ingredeints 

Menthol               15%

Camphor              3%

Purpose 

Menthol            Topical analgesic

Camphor           Topical analgesic

Uses

Useful in Body Aches & Strains

Long Lasting Effect
Fast Acting 

Inactive Ingredients 

• Clove oil
• Turpin oil
• Wintergreen oil
• Eucalyptus oil
• Cinnamon oil
• Peppermint oil
• Nutmeg oil

Directions for use

Apply and rub generously on the affected area until it is absorbed. Repeat if necessary

Warnings

For external use only

• 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 REACH OF CHILDREN

Keep out of children's reach

Other Information 

Apply on small 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 BALM0.8 OZ (25 g)

INGREDIENTS AND APPEARANCE

AMRUT BALM 
menthol, camphor ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57631-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.7 g  in 1 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.75 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CLOVE OIL (UNII: 578389D6D0)
TURNIP-ROOTED CHERVIL OIL (UNII: XKS0X2W3DK)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CINNAMON OIL (UNII: E5GY4I6YCZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
NUTMEG OIL (UNII: Z1CLM48948)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57631-105-08	1 in 1 CARTON	06/14/2017
1		25 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/18/2017

Labeler - InvaTech Pharma Solutions LLC (078602180)

Registrant - InvaTech Pharma Solutions LLC (078602180)

Establishment
Name	Address	ID/FEI	Business Operations
InvaTech Pharma Solutions LLC		078602180	label(57631-105)

Establishment
Name	Address	ID/FEI	Business Operations
BAPS Swaminarayan Herbal Care,A Unit of Divine Energy		921183294	manufacture(57631-105) , analysis(57631-105) , pack(57631-105)