Soothing Pain Relief
FDA Label NDC 64483-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clientele, Inc. for the product Soothing Pain Relief (NDC 64483-008). 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 ingredients, purpose, indications, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Menthol 2%

Purpose

Topical analgesic

Indications

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

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

  • For external use only.

Otc - Do Not Use

  • Avoid contact with the eyes.

Otc - Stop Use

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a Physician.

Otc - When Using

  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

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.

Directions

  • Adults and children 2 years of age and older:
    apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age, consult a Physician.

Inactive Ingredients

Water, Butylene Glycol, Aloe Barbadensis Leaf Juice, Eucalyptus Globulus Leaf Oil, Methyl Salicylate, Camphor, Mentha Piperita (Peppermint) Oil, Silica, Potassium Citrate, Magnesium Carbonate, Oleic Acid, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.

Principal Display Panel - 59.1 Ml Bottle Label

Soothing
Pain Relief

Roll-On

2 Fl Oz (59.1 ml)

Rejuvenetics™

Principal Display Panel (59.1 ml Bottle Label)

Principal Display Panel (59.1 ml Bottle Label)

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