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.

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Active ingredients

Menthol 15.0%

Methyl Salicylate  15%

Purpose

Menthol                    Topical analgesic

Methyl Salicylate      Topical analgesic

Uses

  • Temporarily relieves pain associated with headache, cold, body ache and nasal congestion
  • Provides temporary relief of minor pains of muscles and joints

Warnings

For External use only

  • Avoid contact with eyes
  • Do not use otherwise than as directed

When using this product

  • Do not heat
  • Do not microwave
  • Do not use near an open flame
  • Do not add to hot water or any container where heating water. May cause splattering and result in burns
  • Avoid contact with wounds, mucous membranes, broken or irritated skin
  • Do not bandage tightly or use with heating pad

Stop use of this product and consult a doctor if

  • Condition worsens
  • Redness or irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days or is accompanied by fever, rash, or persistent headaches

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

  • See important warning "When using this product"
  • Adults and children over 12 years
  • Apply and gently massage over the affected area
  • Repeat 2- 3 times daily, or as directed by a doctor
  • Children 12 years or younger: ask a doctor

Other Information

Store at room temperature

Inactive ingredients

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

Questions?

Mail: customercare@amrutanjan.com

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 CARTON11/30/202109/08/2022
130 g in 1 JAR; Type 0: Not a Combination Product
2NDC:53554-020-101 in 1 CARTON11/30/202109/08/2022
250 g in 1 JAR; Type 0: Not a Combination Product
3NDC:53554-020-031 in 1 BLISTER PACK11/30/202109/08/2022
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 finalpart34811/30/202109/19/2022
Labeler - AMRUTANJAN HEALTH CARE LIMITED (650128309)
Registrant - AMRUTANJAN HEALTH CARE LIMITED (650128309)
Establishment
NameAddressID/FEIBusiness Operations
MAKSON HEALTHCARE PRIVATE LIMITED854279690manufacture(53554-020)

Revised: 9/2022
 
AMRUTANJAN HEALTH CARE LIMITED