AMRUTANJAN RELIEF COLD RUB- camphor (synthetic), eucalyptus oil, and menthol 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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AMRUTANJAN RELIEF COLD RUB

Active ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Purpose

Camphor                 Cough suppressant/Topical analgesic

Eucalyptus oil 1.2%    Cough suppressant

Menthol 2.6%             Topical analgesic

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • Provides temporary relief of minor pains of muscles and joints

Warnings

For external use only

  • Do not take by mouth or place in nostrils

Consult a doctor before use if you have

  • A persistent cough may be a seroius condition
  • If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache
  • Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphy-sema, or if cough is accompanied by excessive phlegm (mucus) unless directed by doctor

When using this product

  • Do not heat
  • Do not microwave
  • Keep away from fire or flame
  • Do not add to hot water or any container where heating water. May cause splattering and result in burns
  • Avoid contact with eyes, 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 is present
  • 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 professional 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 2 years and older;
  • Rub on the throat and chest in a thick layer
  • Cover with a warm, dry cloth if desired
  • Clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • Use up to three times daily or as directed by a doctor
  • Children 2 years or younger: ask a doctor

Other Information

Store at room temperature

Inactive ingredients

butylated hydroxy toluene, cedar leaf oil, microcrystalline wax, nutmeg oil, petrolatum, thymol, turpentine oil.

Questions?

Mail : customercare@amrutanjan.com

PRINCIPAL DISPLAY PANAL - 30 g Jar Carton
NDC 53554-030-05

AMRUTANJAN
RELIEF COLD RUBTM
COUGH SUPPRESSANT/TOPICAL ANALGESIC OINTMENT
NET WT: 1.05 OZ (30g)

PRINCIPAL DISPLAY PANAL - 30 g Jar Carton

                                       NDC 53554-030-05


AMRUTANJAN

RELIEF COLD RUBTM

COUGH SUPPRESSANT/TOPICAL ANALGESIC OINTMENT

NET WT: 1.05 OZ (30g)

Relief cold rub 30 g

PRINCIPAL DISPLAY PANAL - 50 g Jar Carton

                                       NDC 53554-030-10

AMRUTANJAN

RELIEF COLD RUBTM

COUGH SUPPRESSANT/TOPICAL ANALGESIC OINTMENT

NET WT: 1.76 OZ (50g)

Relief cold rub 50 g

AMRUTANJAN RELIEF COLD RUB 
camphor (synthetic), eucalyptus oil, and menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53554-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.048 g  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.012 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.026 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
NUTMEG OIL (UNII: Z1CLM48948)  
PETROLATUM (UNII: 4T6H12BN9U)  
THYMOL (UNII: 3J50XA376E)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53554-030-051 in 1 CARTON11/30/202109/08/2022
130 g in 1 JAR; Type 0: Not a Combination Product
2NDC:53554-030-101 in 1 CARTON11/30/202109/08/2022
250 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/30/202109/19/2022
Labeler - AMRUTANJAN HEALTH CARE LIMITED (650128309)
Registrant - AMRUTANJAN HEALTH CARE LIMITED (650128309)
Establishment
NameAddressID/FEIBusiness Operations
MAKSON HEALTHCARE PRIVATE LIMITED854279690manufacture(53554-030)

Revised: 9/2022
 
AMRUTANJAN HEALTH CARE LIMITED