Kool Comfort
FDA Label NDC 52301-365

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dee Cee Laboratories, Inc. for the product Kool Comfort (NDC 52301-365). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredientMenthol 2.5%

Otc - Purpose

PurposeCooling Pain relief

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with · simple backache · arthritis ·strains · bruises · sprains

Warnings

For external use only.FlammableKeep away from excessive heat or open flame.

Otc - Ask Doctor

Ask a doctor before use if you have
  • sensitive skin

Otc - When Using

When using this product
  • avoid contact with the eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not use with other ointments, creams, sprays or liniments
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage
  • wash hands after use with cool water
  • do not use with heating pad or heating devices

Otc - Stop Use

Stop use and ask a doctor if
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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 over:  apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age:  Consult a physician.

Other Information

Store in a cool dry place with lid tightly closed.

Inactive Ingredients

Carbopol 934, FD&C blue #1, esi-cryll ll, herbal extract (ILEX paraguariensis), isopropyl alcohol, neutrol TE, phenonip, and purified water.

Other

Lot. No. & Exp. Date:  See label or bottom of container.Manufactured for:Dee Cee Laboratories Inc., 304 Dee Cee Ct., White House, TN  37188

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