ARTHRITIS PAIN RELIEVER- capsaicin cream 
HPI Health Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Arthritis Pain Reliever

Drug Facts

Active Ingredient

Capsaicin 0.025%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain of muscles and joints associated with:

Warnings

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:

Other information

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

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

Principal Display Panel - 88 ml Bottle Carton
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)

Revised: 12/2013
Document Id: b784f5ff-a1e0-40d4-8367-51936a7b8c66
Set id: 566732ca-7b6e-44e3-9ec9-55ea0ee4279a
Version: 1
Effective Time: 20131224
 
HPI Health Products Inc.