Label: PAINAZIN CP- capsaicin spray
- NDC Code(s): 64058-117-14
- Packager: Concept Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active ingredient
Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)Close
for the temporary relief of minor aches and pains of muscles and joints associated with
- simple backache
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
Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep out of reach of children.
- if swallowed, get medical help or contact a Poison Control center right away
- PREGNANCY OR BREAST FEEDING
- if pregnant or nursing, seek the advice of a health professional before using
- 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
- 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.
- 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.Close
- Questions or comments?
Call 1-888-373-8831 or visit www.conceptlabs.orgClose
- PRINCIPAL DISPLAY PANEL - 118mL Bottle Label
Pain Relieving Spray
with Emu Oil, Glucosamine & MSM
Penetrating Pain Relief
- Simple Backache
Greaseless • Odorless • Stainless
4 FL OZ (118mL)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-117 Route of Administration TOPICAL DEA Schedule 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