ARTHRITIS PAIN RELIEVER- capsaicin cream

Arthritis Pain Reliever by

Drug Labeling and Warnings

Arthritis Pain Reliever by is a Otc medication manufactured, distributed, or labeled by HPI Health Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Capsaicin 0.025%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain of muscles and joints associated with:

• arthritis
• simple backache
• strains
• sprains
• bruises

Warnings

• For external use only.

When using this product

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

Stop use and ask a doctor if

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

If pregnant or breast-feeding, ask a health care 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 over 18 years:

• apply to affected area
• massage into painful area until thoroughly absorbed
• repeat if necessary, but no more than 3 to 4 times daily
• WASH HANDS WITH SOAP AND WATER AFTER APPLYING
• Children 18 years and younger: ask a doctor

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

Abies balsamea, carbomer, cedarwood bark oil, diazolidinyl urea, ethanol, methylparaben, propylene glycol, propylparaben, triethanolamine, water

Questions or comments?

Call us toll-free at (877) 514-3132 between 9am and 4pm (PST), Monday through Friday. Visit us on the website at lakotaherbs.com

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distributed by:
Natural Pain Relief Agency Inc.
Phoenix, AZ 85086

PRINCIPAL DISPLAY PANEL - 88 ml Bottle Carton

LaKOTA
Roll-On Pain Reliever

Arthritis Pain Releiver

Capsaicin – Topical analgesic

3 fl.oz/88ml

INGREDIENTS AND APPEARANCE

ARTHRITIS PAIN RELIEVER 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59092-001
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 mL

Inactive Ingredients
Ingredient Name	Strength
canada balsam (UNII: K304VI98I3)
alcohol (UNII: 3K9958V90M)
carbomer interpolymer type A (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
trolamine (UNII: 9O3K93S3TK)
water (UNII: 059QF0KO0R)
cedrus atlantica bark oil (UNII: ZX5QRE4U60)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59092-001-12	1 in 1 CARTON
1	NDC: 59092-001-01	88 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/19/2014

Labeler - HPI Health Products Inc. (202932864)