United States - English - NLM (National Library of Medicine)
PAINAZIN CP- capsaicin spray
Concept Laboratories, 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.
PAINAZIN-CP THERAPEUTIC PAIN RELIEVING SPRAY
Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)
for the temporary relief of minor aches and pains of muscles and joints associated with
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
When using this product do not get into eyes
avoid contact with other mucous membranes
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
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
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.
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?
Call 1-888-373-8831 or visit www.conceptlabs.org
PRINCIPAL DISPLAY PANEL - 118mL Bottle Label
Pain Relieving Spray
with Emu Oil, Glucosamine & MSM
Penetrating Pain Relief
Greaseless Odorless Stainless
4 FL OZ (118mL)
Product T ype
HUMAN OTC DRUG
Ite m Code (Source )
NDC:6 40 58 -117
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
Ca psa icin (UNII: S0 7O44R1ZM) (Capsaicin - UNII:S0 7O44R1ZM)
Ca psa ic in
0 .0 0 0 25 g in 1 mL
Stre ng th
Wa ter (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
MEDICAGO SATIVA LEAF (UNII: HY3L9 27V6 M)
CYMBO PO GO N SCHO ENANTHUS LEAF (UNII: XF54B1Z2HF)
GLUCO SAMINE HYDRO CHLO RIDE (UNII: 750 W5330 FY)
GINKGO (UNII: 19 FUJ2C58 T)
Concept Laboratories, Inc.
PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)
EMU O IL (UNII: 3448 21WD6 1)
DMDM HYDANTO IN (UNII: BYR0 546 TOW)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PRO PYLPARABEN (UNII: Z8 IX2SC1OH)
Marketing Start Date
Marketing End Date
NDC:6 40 58 -117-14
118 mL in 1 BOTTLE
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
OTC mo no graph no t final
0 1/27/20 11
Concept Laboratories, Inc. (962282612)
Ad d re s s
Busine ss Ope rations
Co ncept Labo rato ries, Inc.
9 6 228 26 12