Label: ARTHRITIS PAIN RELIEVER- capsaicin cream
Contains inactivated NDC Code(s)
NDC Code(s): 59092-001-01, 59092-001-12
- Packager: HPI Health Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 24, 2013
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- 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
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 88 ml Bottle Carton
INGREDIENTS AND APPEARANCE
ARTHRITIS PAIN RELIEVER
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)