AMRUTANJAN RELIEF STRONG PAIN BALM- menthol, methyl salicylate ointment 
AMRUTANJAN HEALTH CARE LIMITED

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.

----------

Active ingredients

Menthol 15.0%

Methyl Salicylate  15%

Purpose

Menthol                    Topical analgesic

Methyl Salicylate      Topical analgesic

Uses

Warnings

For External use only

When using this product

Stop use of this product and consult a doctor if

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare personal before use

Keep out of reach of children, if swallowed, get medical help or contact a poison control center right away

Directions

Other Information

Store at room temperature

Inactive ingredients

butylated hydroxy toluene, cetostreayl alcohol, microcrystalline wax, paraffin, petrolatum

Questions?

Call 1-888-611-6811

NDC 53554-020-05
AMRUTANJAN
RELIEF Strong PAIN BALMTM
PAIN RELIEVING OINTMENT
NET WT: 1.05 OZ (30g)

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton

image description

AMRUTANJAN RELIEF STRONG PAIN BALM 
menthol, methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53554-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.15 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53554-020-051 in 1 CARTON08/12/2015
130 g in 1 JAR; Type 0: Not a Combination Product
2NDC:53554-020-101 in 1 CARTON08/12/2015
250 g in 1 JAR; Type 0: Not a Combination Product
3NDC:53554-020-031 in 1 BLISTER PACK08/12/2015
39 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/23/2015
Labeler - AMRUTANJAN HEALTH CARE LIMITED (650128309)
Registrant - AMRUTANJAN HEALTH CARE LIMITED (650128309)
Establishment
NameAddressID/FEIBusiness Operations
MAKSON INDUSTRIES PRIVATE LIMITED650553980manufacture(53554-020)

Revised: 11/2019
Document Id: 254a7102-cbc1-475a-a60f-e28ba0d5df7a
Set id: 206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27
Version: 7
Effective Time: 20191115
 
AMRUTANJAN HEALTH CARE LIMITED