WALGREENS ARTHRITIS PAIN RELIEF CAPSAICIN ANALGESIC- capsaicin cream

Walgreens Arthritis Pain Relief Capsaicin Analgesic by

Drug Labeling and Warnings

Walgreens Arthritis Pain Relief Capsaicin Analgesic by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Garcoa, Inc, Sigan Industries INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Capsaicin 0.1%

Purpose

Topical Analgesic

Uses

for the temporarily relief of minor aches and pains of muscles and joints associated with

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

Warnings

For external use only: Be sure to read product brochure before using. TEST FIRST ON SMALL AREA OF SKIN.

When using this product

• ♦ use only as directed
• ♦ do not bandage tightly
• ♦ do not use with a heating pad
• ♦ avoid contact with eyes and mucous membranes
• ♦ do not apply to wounds, damaged, broken or irritated skin
• ♦ a slight burning sensation may occur upon application but generally disappears in several days
• ♦ if severe burning occurs, discontinue use
• ♦ do not expose the treated area to heat or direct sunlight
• ♦ do not use if allergic to capsicum or chili peppers

Stop use and consult a doctor if

• ♦ condition worsens
• ♦ symptoms persist for more than 7 days or clear up and occur again within a few days
• ♦ redness is present
• ♦ irritation develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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

Directions

• ♦ adults and children 18 years of age and older: apply to affected area not more than 3 to 4 times daily
• ♦ massage into area until thoroughly absorbed
• ♦ WASH HANDS WITH SOAP AND WATER AFTER APPLYING
• ♦ children under 18 years of age: consult a doctor

Other information

store at room temperature

Inactive ingredients

acrylates/C10-30 slkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, sodium hydroxide, steareth-100, stearic acid, stearyl alcohol, water

Questions or comments?

1-800-925-4733

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton

ARTHRITIS PAIN RELIEF
Capsaicin

CAPSAICIN 0.1% / TOPICAL ANALGESIC CREAM

NET WT 1.5 OZ (42.5 g)

INGREDIENTS AND APPEARANCE

WALGREENS ARTHRITIS PAIN RELIEF CAPSAICIN ANALGESIC 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0837
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
Cetyl Acetate (UNII: 4Q43814HXS)
METHYLPARABEN (UNII: A2I8C7HI9T)
PPG-20 Methyl Glucose Ether Distearate (UNII: 0057334FAB)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Sodium Hydroxide (UNII: 55X04QC32I)
Steareth-100 (UNII: 4OH5W9UM87)
Stearic Acid (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
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: 0363-0837-01	1 in 1 CARTON	05/03/2010
1		42.5 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	05/03/2010

Labeler - Walgreen Company (008965063)

Registrant - Garcoa, Inc (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(0363-0837)