Icy Cool
FDA Label NDC 63868-633

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by C.d.m.a. Inc. for the product Icy Cool (NDC 63868-633). 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, when using this product, stop use and ask a doctor if, flammable, 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

Natural Menthol 5.5%

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis,
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

For external use only

When Using This Product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days.

Stop Use And Ask A Doctor If

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

  • keep away from fire of flame

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 of contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

  • apply generously to affected area
  • message into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily

    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    Children 12 years or younger, ask a doctor

Inactive Ingredients –

AloeVera, Carbomer, FD&C Blue #1, Glycerine USP, Ilex Paraguariensis Extract, Isopropyl Alcohol USP, Camphor, Propylene Glycol USP, Methyl Paraben, Purified Water, Silicon Dioxide, Triethanolamine, Vitamin E

Principal Display Panel - 4 Oz. Tube Label

QC Quality Choice

NDC 63868-0633-18

*Compare to BIOFREEZE®
Pain Relieving Gel

Maximum Strength

Icy CoolTM

Pain Relieving Gel

Natural Menthol 5.5% | Topical Analgesic

Relief From:
Aches and pains associated with strains, sprains, backaches, bruises and arthritis

With Aloe

1 Tube 4oz./118ml.

Principal Display Panel (4 oz. Tube Label)

Principal Display Panel (4 oz. Tube Label)

* Please review the disclaimer below.