Icy Cold Cool Pain Relieving
FDA Label NDC 71323-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Compass Health Brands Corp. for the product Icy Cold Cool Pain Relieving (NDC 71323-101). 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 active ingredients, purpose, uses, warnings, otc - do not use, 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

Active Ingredients

MENTHOL 3.9%

CAMPHOR 0.4%

Purpose

TOPICAL ANALGESIC

COUNTER IRRITANT

Uses

temporary relief of

  • Arthritis
  • Backache
  • Strains/Sprains

Warnings

FOR EXTERNAL USE ONLY

Otc - Do Not Use

Do not use near eyes, mouth, mucus membranes, genitals, cuts, rashes and sores. If contact occurs, flush with cold water. Do not use with heating pad or device, or under bandages. Do not use if pregnant or breastfeeding. Please consult your physician prior to use. Do not apply to wounds or damaged skin.

Otc - Stop Use

Stop use and ask a doctor if irritation persists.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If accidentally ingested, seek medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Rub in thoroughly until gel is absorbed.

Inactive Ingredients

Water, Isopropyl Alcohol, Propylene Glycol, Glycerin, Carbomer, Ilex Paraguariensis Leaf Extract, Hydrated Silica, Aminomethyl Propanol, Methyl Paraben, Uncaria Tomentosa Extract, Boswelia Serrata Extract, Camphor for scent.

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