Pure Relief
FDA Label NDC 64058-118

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 64058-118). 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, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, 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)
#CL10010

Otc - Purpose

Active ingredientPurpose
Capsicum Oleoresin 0.0625%Pain
(Containing Capsaicin 0.025%)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.

  • do not apply to wounds or damaged skin

Otc - When Using

When using this product do not get into eyes

  • do not bandage tightly
  • do not use with heating pad, wrap, hot water bottle or any heating element.

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

Directions

  • Children under 12 years of age consult a physician
  • 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
  • A burning sensation may occur upon inital application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.

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?

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Principal Display Panel - 118 Ml Bottle Label

Pure Relief

Penetrating
Pain Relief Spray
with Capsaicin

Temporary relieves
joint & arthritis pain in

  • Hips
  • Knees & Elbows
  • Hands & Feet
  • And more

    • 4 FL OZ (118mL)

    Principal Display Panel (118 mL Bottle Label)

    Principal Display Panel (118 mL Bottle Label)

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