RUGBY PAIN RELIEVING ANALGESIC- menthol, unspecified form and methyl salicylate cream

Rugby Pain Relieving by

Drug Labeling and Warnings

Rugby Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Garcoa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Menthol 1.0%	Topical Analgesic
Methyl Salicylate 15.0%	Topical Analgesic

Use

For the temporary relief of minor aches and pains of muscles and joints associated with

• ♦ arthritis
• ♦ simple backache
• ♦ strains
• ♦ sprains

Warnings

For external use only

Do not use

• ♦ immediately after shower or bath
• ♦ with a heating pad
• ♦ on wounds, damaged, broken or irritated skin

When using this product

• ♦ use only as directed
• ♦ do not swallow
• ♦ do not bandage tightly
• ♦ avoid contact with eyes and mucous membranes

Stop and ask a doctor if

• ♦ skin redness or irritation develops
• ♦ condition worsens or pain lasts for more than 7 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 right away.

Directions

• ♦ adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
• ♦ children under 12 years: ask a doctor.

Other information

Store at room temperature 15° - 30°C (59°F – 86°F).

Inactive ingredients

Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Methylparaben, Polysorbate 60, Propylparaben, Sodium Hydroxide, Sodium Lauryl Sulfate, Water

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

NDC: 0536-1101-45

Rugby®
MAXIMUM STRENGTH

PAIN RELIEVING
CREAM

Net Wt 3 oz (85 g)

INGREDIENTS AND APPEARANCE

RUGBY PAIN RELIEVING   ANALGESIC
menthol, unspecified form and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 1 mL
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Dimethicone (UNII: 92RU3N3Y1O)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Polysorbate 60 (UNII: CAL22UVI4M)
Propylparaben (UNII: Z8IX2SC1OH)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1101-45	1 in 1 CARTON	05/11/2016
1		85 mL in 1 TUBE; 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	05/11/2016

Labeler - Rugby Laboratories (079246066)

Registrant - Garcoa, Inc. (103039178)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(0536-1101)