AMRUTANJAN RELIEF STRONG PAIN BALM- menthol, methyl salicylate ointment

AMRUTANJAN RELIEF STRONG PAIN BALM by

Drug Labeling and Warnings

AMRUTANJAN RELIEF STRONG PAIN BALM 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

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?

Call 1-888-611-6811

NDC:

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

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton

INGREDIENTS AND APPEARANCE

AMRUTANJAN RELIEF STRONG PAIN BALM 
menthol, methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53554-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.15 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53554-020-05	1 in 1 CARTON	08/12/2015
1		30 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 53554-020-10	1 in 1 CARTON	08/12/2015
2		50 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 53554-020-03	1 in 1 BLISTER PACK	08/12/2015
3		9 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 not final	part348	04/23/2015

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(53554-020)