NOBLE LION MEDICATED BALM- methyl salicylate and menthol liniment

Noble Lion Medicated Balm by

Drug Labeling and Warnings

Noble Lion Medicated Balm by is a Otc medication manufactured, distributed, or labeled by ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC, Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Methyl Salicylate 30%

Menthol 14.5%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, bruises, sprains and strains.

Warnings

• FOR EXTERNAL USE ONLY

When using this product

• Avoid contact with eyes and mucous membranes
• Do not apply to wounds or damaged skin
• Do not bandage tightly or use heating pad.

Stop use and ask a doctor if

• Condition worsens
• Symptoms persist for more than seven (7) days
• Symptoms clear up and occur again within a few days.

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 12 years of age and older: apply to affected areas not more than 3 to 4 times daily
• Children under 12 years of age: consult a doctor before use.

Other Information

• This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive ingredients

Men's Mountain Spice

Paraffinum Liquidum (Mineral) Oil, Alcohol Denat, Chlorophyll, Vegetable Oil, and Fragrance

Men's Original Scent

Paraffinum Liquidum (Mineral) Oil, Alcohol Denat, Chlorophyll, Vegetable Oil, Rosa Damascena Flower Oil, and Fragrance

Men's Sport Scent

Paraffinum Liquidum (Mineral) Oil, Alcohol Denat, Chlorophyll, Vegetable Oil, and Fragrance

Women's Extra StrengthJasmine

Paraffinum Liquidum (Mineral) Oil, Alcohol Denat, and Fragrance

Women's Gardenia

Paraffinum Liquidum (Mineral) Oil, Alcohol Denat, and Fragrance

Women's New Woman

Paraffinum Liquidum (Mineral) Oil, Alcohol Denat, and Fragrance

Package/Label Principal Display Panel - Men's Mountain Spice

NDC: 50462-113-05

NOBLE LION

MEDICATED BALM

Provides PENETRATING PAIN RELIEF

Men's Mountain Spice

NOBLE LION IS BASED ON AN INGREDIENT THAT HAS BEEN USED FOR CENTURIES AND IS NOW BEING SOLD WORLDWIDE

0.5 Fl. Oz. (15ml)

Distributed By:

ABBP, LLC

Natural Healthcare Products Company

P.O. Box 30033

Charlotte, NC 28230 USA

www.MYNOBLELION.com

PRODUCT OF USA

Carton Label - Men's Mountain Spice

Package/Label Principal Display Panel - Men's Original Scent

NDC: 50462-115-05

NOBLE LION

MEDICATED BALM

Provides PENETRATING PAIN RELIEF

Men's Original Scent

NOBLE LION IS BASED ON AN INGREDIENT THAT HAS BEEN USED FOR CENTURIES AND IS NOW BEING SOLD WORLDWIDE

0.5 Fl. Oz. (15ml)

Distributed By:

ABBP, LLC

Natural Healthcare Products Company

P.O. Box 30033

Charlotte, NC 28230 USA

www.MYNOBLELION.com

PRODUCT OF USA

Carton Label - Men's Original Scent

Package/Label Principal Display Panel - Men's Sport Scent

NDC: 50462-119-05

NOBLE LION

MEDICATED BALM

Provides PENETRATING PAIN RELIEF

Men's Sport Scent

NOBLE LION IS BASED ON AN INGREDIENT THAT HAS BEEN USED FOR CENTURIES AND IS NOW BEING SOLD WORLDWIDE

0.5 Fl. Oz. (15ml)

Distributed By:

ABBP, LLC

Natural Healthcare Products Company

P.O. Box 30033

Charlotte, NC 28230 USA

www.MYNOBLELION.com

PRODUCT OF USA

Carton Label - Men's Sport Scent

Package/Label Principal Display Panel - Women's Extra Strength Jasmine

NDC: 50462-110-05

NOBLE LION

MEDICATED BALM

Provides PENETRATING PAIN RELIEF

Women's Extra Strength Jasmine

NOBLE LION IS BASED ON AN INGREDIENT THAT HAS BEEN USED FOR CENTURIES AND IS NOW BEING SOLD WORLDWIDE

0.5 Fl. Oz. (15ml)

Distributed By:

ABBP, LLC

Natural Healthcare Products Company

P.O. Box 30033

Charlotte, NC 28230 USA

www.MYNOBLELION.com

PRODUCT OF USA

Carton Label - Women's Extra Strength Jasmine

Package/Label Principal Display Panel - Women's Gardenia

NDC: 50462-107-05

NOBLE LION

MEDICATED BALM

Provides PENETRATING PAIN RELIEF

Women's Gardenia

NOBLE LION IS BASED ON AN INGREDIENT THAT HAS BEEN USED FOR CENTURIES AND IS NOW BEING SOLD WORLDWIDE

0.5 Fl. Oz. (15ml)

Distributed By:

ABBP, LLC

Natural Healthcare Products Company

P.O. Box 30033

Charlotte, NC 28230 USA

www.MYNOBLELION.com

PRODUCT OF USA

Carton Label - Women's Gardenia

Package/Label Principal Display Panel - Women's New Woman

NDC: 50462-114-05

NOBLE LION

MEDICATED BALM

Provides PENETRATING PAIN RELIEF

Women's New Woman

NOBLE LION IS BASED ON AN INGREDIENT THAT HAS BEEN USED FOR CENTURIES AND IS NOW BEING SOLD WORLDWIDE

0.5 Fl. Oz. (15ml)

Distributed By:

ABBP, LLC

Natural Healthcare Products Company

P.O. Box 30033

Charlotte, NC 28230 USA

www.MYNOBLELION.com

PRODUCT OF USA

Carton Label - Women's New Woman

INGREDIENTS AND APPEARANCE

NOBLE LION MEDICATED BALM 
methyl salicylate and menthol liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50462-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	30 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ALCOHOL (UNII: 3K9958V90M)
CORN OIL (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50462-113-05	1 in 1 CARTON
1		15 mL in 1 BOTTLE
2	NDC: 50462-113-11	1 in 1 CARTON
2		30 mL in 1 BOTTLE
3	NDC: 50462-113-22	1 in 1 CARTON
3		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/04/2012

NOBLE LION MEDICATED BALM 
methyl salicylate and menthol liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50462-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	30 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ALCOHOL (UNII: 3K9958V90M)
CORN OIL (UNII: 8470G57WFM)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50462-115-05	1 in 1 CARTON
1		15 mL in 1 BOTTLE
2	NDC: 50462-115-11	1 in 1 CARTON
2		30 mL in 1 BOTTLE
3	NDC: 50462-115-22	1 in 1 CARTON
3		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/04/2012

NOBLE LION MEDICATED BALM 
methyl salicylate and menthol liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50462-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	30 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ALCOHOL (UNII: 3K9958V90M)
CORN OIL (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50462-119-05	1 in 1 CARTON
1		15 mL in 1 BOTTLE
2	NDC: 50462-119-11	1 in 1 CARTON
2		30 mL in 1 BOTTLE
3	NDC: 50462-119-22	1 in 1 CARTON
3		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/04/2012

NOBLE LION MEDICATED BALM 
methyl salicylate and menthol liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50462-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	30 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50462-110-05	1 in 1 CARTON
1		15 mL in 1 BOTTLE
2	NDC: 50462-110-11	1 in 1 CARTON
2		30 mL in 1 BOTTLE
3	NDC: 50462-110-22	1 in 1 CARTON
3		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/04/2012

NOBLE LION MEDICATED BALM 
methyl salicylate and menthol liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50462-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	30 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50462-107-05	1 in 1 CARTON
1		15 mL in 1 BOTTLE
2	NDC: 50462-107-11	1 in 1 CARTON
2		30 mL in 1 BOTTLE
3	NDC: 50462-107-22	1 in 1 CARTON
3		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/04/2012

NOBLE LION MEDICATED BALM 
methyl salicylate and menthol liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50462-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	30 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50462-114-05	1 in 1 CARTON
1		15 mL in 1 BOTTLE
2	NDC: 50462-114-11	1 in 1 CARTON
2		30 mL in 1 BOTTLE
3	NDC: 50462-114-22	1 in 1 CARTON
3		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/04/2012

Labeler - ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC (078453019)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE(50462-113, 50462-115, 50462-119, 50462-110, 50462-107, 50462-114)