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

AMRUTANJAN RELIEF COLD RUB by

Drug Labeling and Warnings

AMRUTANJAN RELIEF COLD RUB by is a Otc medication manufactured, distributed, or labeled by AMRUTANJAN HEALTH CARE LIMITED, MAKSON INDUSTRIES PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

Call 1-888-611-6811

PRINCIPAL DISPLAY PANAL - 30 g Jar CartonNDC:

53554-030-05 AMRUTANJAN RELIEF COLD RUBTM COUGH SUPPRESSANT/TOPICAL ANALGESIC OINTMENTNET 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)

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53554-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 OIL	0.012 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.026 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53554-030-05	1 in 1 CARTON	04/22/2015
1		30 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 53554-030-10	1 in 1 CARTON	04/22/2015
2		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/16/2015

Labeler - AMRUTANJAN HEALTH CARE LIMITED (650128309)

Registrant - AMRUTANJAN HEALTH CARE LIMITED (650128309)

Establishment
Name	Address	ID/FEI	Business Operations
MAKSON INDUSTRIES PRIVATE LIMITED		650553980	manufacture(53554-030)