- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with heating pad, pack, wrap, hot water bottle or any heating element
- PREGNANCY OR BREAST FEEDING
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Directions
- Children under 12 years of age consult a physician
- To avoid inhaling product, hold bottle close to skin while spraying
- 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
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Other information
- It is recommended to test for skin sensitivity prior to use. Apply product to a small area, follow the directions and wait 24 hours. Proceed with application if no adverse reaction.
- A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.
- If applying product to hands, wait 30 minutes before washing.
- Avoid water, heat, or direct sunlight while using product.
- If wearing contact lenses, insert prior to application and avoid touching them after applying product.
- If eye contact occurs, flush immediately with water.
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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?
- PRINCIPAL DISPLAY PANEL - 118mL Bottle Label
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INGREDIENTS AND APPEARANCE
PAINAZIN CP
capsaicin sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 0.00025 g in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDICAGO SATIVA 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64058-117-14 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/27/2011 Labeler - Concept Laboratories, Inc. (962282612) Establishment Name Address ID/FEI Business Operations Concept Laboratories, Inc. 962282612 MANUFACTURE