Pain Relieving Cooling Gel
FDA Label NDC 72342-020

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J.r. Watkins, Llc. for the product Pain Relieving Cooling (NDC 72342-020). 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, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

MENTHOL 3%

Purpose

EXTERNAL ANALGESIC

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.

Flammable: Keep away from fire or flame.

Do Not Use

  • on wounds or damaged skin
  • with a heading pad

When Using This Product

  • avoid contact with eyes, nostrils and mouth
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • rash or irritation occurs

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

  • Use only as directed
  • Adults and children 2 years and older: Apply liberally to painful area not more than 3-4 times daily.
  • Children under 2 years of age: Ask a doctor.
  • Wash hands carefully after using

Other Information

  • do not use if tamper evident seal is not intact
  • store away from children
  • store in dry, well-ventilated conditions at room temperature (59-77°F)

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, SD alcohol 40B, tromethamine, water

Questions Or Comments?

1-800-243-9423

Principal Display Panel - 93 G Tube Label

97% NATURAL

ESTD
1868

J.R.
WATKINS
REMEDIES FOR BODY™

PAIN RELIEVING
COOLING
GEL

NATURAL
MENTHOL

TEMPORARY
RELIEF FOR
MUSCLES & JOINTS

NET WT. 3.3 OZ (93 g)

Principal Display Panel (93 g Tube Label)

Principal Display Panel (93 g Tube Label)

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