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 Bryant Ranch Prepack. 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

HOW SUPPLIED

NDC: 72162-2156-2: 85 g in a TUBE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PRINCIPAL DISPLAY PANEL

Pain Relieving Cream

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: 72162-2156(NDC:0536-1101)
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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: 72162-2156-2	1 in 1 CARTON	02/02/2024
1		85 g 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 Drug	M017	05/11/2016

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(72162-2156) , RELABEL(72162-2156)