Label: PURE RELIEF PENETRATING PAIN RELIEF- capsaicin gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 64058-118-14 - Packager: Concept Laboratories, 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.
Drug Label Information
Updated February 11, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
For external use only.
- do not apply to wounds or damaged skin
When using this product do not get into eyes
- do not bandage tightly
- do not use with heating pad, wrap, hot water bottle or any heating element.
-
Directions
- Children under 12 years of age consult a physician
- Apply a thin layer to affected area not more than 3 to 4 times daily
- Gently massage into the skin until fully absorbed
- Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
- A burning sensation may occur upon inital application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.
-
Inactive ingredients
Water (Aqua), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Glucosamine HCl, Medicago Sativa (Alfalfa) Extract, Ginkgo Biloba Leaf Extract, Cymbopogon Schoenanthus Extract, Seed of Celosia Argentea Extract, Dimethyl Sulfone, Panax Ginseng Root Extract, Polysorbate 20, Tocopheryl Acetate, Emu Oil, Propylene Glycol, DMDM Hydantoin. Methylparaben, Propylparaben.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
PURE RELIEF PENETRATING PAIN RELIEF
capsaicin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 0.0295 g in 118 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) PEG-75 LANOLIN (UNII: 09179OX7TB) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALFALFA LEAF (UNII: HY3L927V6M) CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) GINKGO (UNII: 19FUJ2C58T) POLYSORBATE 20 (UNII: 7T1F30V5YH) EMU OIL (UNII: 344821WD61) DMDM HYDANTOIN (UNII: BYR0546TOW) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASIAN GINSENG (UNII: CUQ3A77YXI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64058-118-14 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/06/2013 Labeler - Concept Laboratories, Inc. (962282612) Establishment Name Address ID/FEI Business Operations Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-118)
