RUGBY CAPSAICIN EXTERNAL ANALGESIC- capsaicin cream

Rugby Capsaicin by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Capsaicin 0.025%

Purpose

External 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 the 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 use 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.

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° - 86°F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water

Questions or comments?

Call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

Mfd for:
Rugby Laboratories, Inc.
Duluth, Georgia 30097

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

NDC: 0536-2525-25

Rugby®

SATISFACTION GUARANTEED
Rugby
OR YOUR MONEY BACK

Capsaicin Cream, 0.025%

External Analgesic
Penetrating Pain Relief

Net Wt 2.1 oz (60 g)

INGREDIENTS AND APPEARANCE

RUGBY CAPSAICIN   EXTERNAL ANALGESIC
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-2525
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
Cetyl Acetate (UNII: 4Q43814HXS)
Methylparaben (UNII: A2I8C7HI9T)
PPG-20 Methyl Glucose Ether Distearate (UNII: 0057334FAB)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Steareth-100 (UNII: 4OH5W9UM87)
Stearic Acid (UNII: 4ELV7Z65AP)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Trolamine (UNII: 9O3K93S3TK)
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: 0536-2525-25	1 in 1 CARTON	03/01/2012
1		60 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	03/01/2012

Labeler - Rugby Laboratories (079246066)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries, Inc.		255106239	MANUFACTURE(0536-2525)