Pure Relief™

Pure Relief™
SPL v2
SPL
SPL Set ID 5523f9bf-6ff6-4fd3-98ff-ada1bfa03b6b
Route
TOPICAL
Published
Effective Date 2017-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (2.5 mg)
Inactive Ingredients
Water Aloe Vera Leaf Methyl Diisopropyl Propionamide Ethyl Menthane Carboxamide Menthyl Lactate, (-)- Lauryl Laurate Starch, Corn Hydrated Silica Glucosamine Hydrochloride Dimethyl Sulfone Glycerin Sunflower Oil Alfalfa Arnica Montana Flower Cymbopogon Schoenanthus Top Rosemary Mentha Piperita Leaf Asian Ginseng Ginkgo Flax Seed Celosia Argentea Seed Acai Edetate Disodium Emu Oil Polysorbate 20 .alpha.-tocopherol Acetate Butylene Glycol Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Cetearyl Isononanoate Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glyceryl Monostearate Ceteareth-12 Cetyl Palmitate Peppermint Oil Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-12-06

Description

Drug Facts

Purpose

Pain Relieving


Medication Information

Purpose

Pain Relieving

Description

Drug Facts

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
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

Stop use and ask a doctor if condition worsens

  • if symptoms persist for more than 7 days
  • clear up and occur again within a few days
Section 50567-7

When using this product avoid eye contact

  • avoid contact with mucous membranes
Section 50570-1
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, wrap, hot water bottle or any heating element.
Section 53414-9
  • if pregnant or nursing, seek the advice of a health professional before using
Warnings

For external use only.

Directions
  • for adults only
  • apply a thin layer to affected area not more than 4 times daily
  • gently massage into the skin until fully absorbed
  • wash hands with soap and water after each application to avoid spreading to sensitive mucous membranes
Active Ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Other Information
  • Excess product can be removed 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), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita (Peppermint) Oil, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.

Principal Display Panel 113 G Jar Label

EFFECTIVE RELIEF

PURE RELIEF™

PAIN RELIEVING CREAM

WITH MOISTURIZING ALOE,

EMU OIL & GLUCOSAMINE

NET WT. 4 OZ (113 g)


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
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)

Stop use and ask a doctor if condition worsens

  • if symptoms persist for more than 7 days
  • clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product avoid eye contact

  • avoid contact with mucous membranes
Section 50570-1 (50570-1)
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, 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
Purpose

Pain Relieving

Warnings

For external use only.

Directions
  • for adults only
  • apply a thin layer to affected area not more than 4 times daily
  • gently massage into the skin until fully absorbed
  • wash hands with soap and water after each application to avoid spreading to sensitive mucous membranes
Active Ingredient (Active ingredient)

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Other Information (Other information)
  • Excess product can be removed 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), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita (Peppermint) Oil, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.

Principal Display Panel 113 G Jar Label (PRINCIPAL DISPLAY PANEL - 113 g Jar Label)

EFFECTIVE RELIEF

PURE RELIEF™

PAIN RELIEVING CREAM

WITH MOISTURIZING ALOE,

EMU OIL & GLUCOSAMINE

NET WT. 4 OZ (113 g)


Advanced Ingredient Data


Raw Label Data

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