AMRUTANJAN RELIEF PAIN BALM- camphor , menthol, methyl salicylate ointment

AMRUTANJAN RELIEF PAIN BALM by

Drug Labeling and Warnings

AMRUTANJAN RELIEF 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]

AMRUTANJAN RELIEF PAIN BALM Active ingredients

Camphor 10.0%

Menthol 8.0%

Methyl Salicylate 14.0%

Purpose

Camphor                           Topical analgesic

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 add 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 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 doctor

Other Information

Store at room temperature

Inactive ingredients

butylated hydroxy toluene, cinnamon leaf oil, citronella oil, clove oil, east indian lemongrass oil, eucalyptus oil, light mineral oil, microcrystalline wax, paraffin, petrolatum, quinoline yellow (D&C yellow no.11).

Questions?

Call 1-888-611-6811

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton                                               NDC:

53554-010-05 AMRUTANJANRELIEFPAIN BALMTM PAIN RELIEVING OINTMENT NET WT: 1.05 OZ (30g)

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton

INGREDIENTS AND APPEARANCE

AMRUTANJAN RELIEF PAIN BALM 
camphor , menthol, methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53554-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.1 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.08 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.14 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CINNAMON LEAF OIL (UNII: S92U8SQ71V)
CITRONELLA OIL (UNII: QYO8Q067D0)
CLOVE OIL (UNII: 578389D6D0)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53554-010-05	1 in 1 CARTON	06/29/2015
1		30 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 53554-010-10	1 in 1 CARTON	06/29/2015
2		50 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 53554-010-03	1 in 1 BLISTER PACK	06/29/2015
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(53554-010)