RUGBY ARTHRITIS PAIN RELIEVING TOPICAL ANALGESIC- capsaicin cream

Rugby Arthritis Pain Relieving by

Drug Labeling and Warnings

Rugby Arthritis 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

Capsaicin 0.075%

Purpose

Topical Analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to:

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

Warnings

For external use only

Read all warnings and directions before use. TEST FIRST ON SMALL AREA OF SKIN.

Do not use

• ♦ on wounds or damaged skin
• ♦ if you are allergic to capsicum or chili peppers

When using this product

• ♦ you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
• ♦ avoid contact with eyes, lips, nose and mucous membranes
• ♦ do not tightly wrap or bandage the treated area
• ♦ do not apply heat to the treated area immediately before or after use

Stop and ask a doctor if

• ♦ condition worsens or does not improve after regular use
• ♦ severe burning persists or blistering occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

If pregnant or breast feeding, ask a health professional before use.

Directions

Adults and children 18 years of age and older:

• ♦ apply a thin film of cream to affected area and gently rub in until fully absorbed
• ♦ unless treating hands, wash hands thoroughly with soap and water immediately after application
• ♦ for best results, apply 3 to 4 times daily.

Children under 18 years: ask a doctor

Other information

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

Inactive ingredients

benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-100 stearate, petrolatum, sorbitol, water

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

NDC: 0536-1118-25

Rugby ®

COMPARE TO
ZOSTRIX® HP
ACTIVE INGREDIENT*

HIGH POTENCY
ARTHRITIS PAIN RELIEVING CREAM
0.075% CAPSAICIN TOPICAL ANALGESIC

Odor Free Formula Clinically Tested Active Ingredient
Net Wt 2 oz (57 g)

INGREDIENTS AND APPEARANCE

RUGBY ARTHRITIS PAIN RELIEVING   TOPICAL ANALGESIC
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Benzyl Alcohol (UNII: LKG8494WBH)
Cetyl Alcohol (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
PEG-100 Stearate (UNII: YD01N1999R)
Petrolatum (UNII: 4T6H12BN9U)
Sorbitol (UNII: 506T60A25R)
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: 0536-1118-25	1 in 1 CARTON	05/24/2017
1		57 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 NOT FINAL	part348	05/24/2017

Labeler - Rugby Laboratories (079246066)

Registrant - Garcoa, Inc (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc		036464697	MANUFACTURE(0536-1118)