Pure Relief
FDA Label NDC 64058-356

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Concept Laboratories, Inc. for the product Pure Relief (NDC 64058-356). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Manufactured by Concept Laboratories, Inc.
Chicago, IL 60642 (USA) www.conceptlabs.org
#CL9783-R2

Active Ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpose

Pain Relieving

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only.

Otc - Do Not Use

  • 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.

Otc - When Using

When using this product avoid eye contact

  • avoid contact with mucous membranes

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away

Otc - Pregnancy Or Breast Feeding

  • if pregnant or nursing, seek the advice of a health professional before using

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

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)

Principal Display Panel (113 g Jar Label)

Principal Display Panel (113 g Jar Label)

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