PAINAZIN CP- capsaicin spray

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)
Available from:
Concept Laboratories, Inc.
INN (International Name):
Capsaicin
Composition:
Capsaicin 0.00025 g in 1 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain Relieving for the temporary relief of minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - sprains - bruises
Authorization status:
OTC monograph not final
Authorization number:
64058-117-14

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

Drug Facts

Active ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpos e

Pain Relieving

Us es

for the temporary relief of minor aches and pains of muscles and joints associated with

simple backache

arthritis

strains

sprains

bruises

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

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

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

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.

Questions or comments?

Call 1-888-373-8831 or visit www.conceptlabs.org

PRINCIPAL DISPLAY PANEL - 118mL Bottle Label

NDC 64058-117-14

Painazin-CP

Therapeutic

Pain Relieving Spray

with Emu Oil, Glucosamine & MSM

Penetrating Pain Relief

Arthritis

Simple Backache

Strains

Sprains

Greaseless Odorless Stainless

4 FL OZ (118mL)

PAINAZIN CP

capsaicin spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 40 58 -117

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

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

Inactive Ingredients

Ingredient Name

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)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 40 58 -117-14

118 mL in 1 BOTTLE

Marketing Information

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

pa rt348

0 1/27/20 11

Labeler -

Concept Laboratories, Inc. (962282612)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co ncept Labo rato ries, Inc.

9 6 228 26 12

MANUFACTURE

Revised: 7/2011

Similar products

Search alerts related to this product

Share this information