AMRUT BALM- menthol, camphor ointment
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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BAPS AMRUT BALM

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 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 BALM
0.8 OZ (25 g)

image description

AMRUT BALM
menthol, camphor ointment

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/18/2017

Labeler - InvaTech Pharma Solutions LLC (078602180)

Registrant - InvaTech Pharma Solutions LLC (078602180)

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

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