painazin-cp therapeutic pain relieving spray

painazin-cp therapeutic pain relieving spray
SPL v2
SPL
SPL Set ID e68893b5-e150-4f89-82dc-255ecc87b980
Route
topical
Published
Effective Date 2011-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
capsaicin (0.00025 g)
Inactive Ingredients
water glycerin dimethyl sulfone aloe vera leaf medicago sativa leaf cymbopogon schoenanthus leaf glucosamine hydrochloride ginkgo polysorbate 20 emu oil dmdm hydantoin propylene glycol methylparaben propylparaben

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2011-01-27

Purpose

Pain Relieving

Description

Drug Facts


Medication Information

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
Purpose

Pain Relieving

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.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
Section 50566-9

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

Section 50567-7

When using this product do not get into eyes

  • avoid contact with other mucous membranes
Section 50570-1

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
Section 53414-9
  • if pregnant or nursing, seek the advice of a health professional before using
Active Ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

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)


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
Purpose

Pain Relieving

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 (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 (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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not get into eyes

  • avoid contact with other mucous membranes
Section 50570-1 (50570-1)

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
Section 53414-9 (53414-9)
  • if pregnant or nursing, seek the advice of a health professional before using
Active Ingredient (Active ingredient)

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel 118ml Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

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