Icy Freeze Gel
FDA Label NDC 66902-165

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Essentials, Inc. for the product Icy Freeze (NDC 66902-165). 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, ask a doctor before use if you, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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ICY FREEZE COOLING PAIN RELIEF

Drug Facts

Active Ingredient

Menthol 3.5%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains associated with:

  • Tendonitis
  • Strains
  • Sprains
  • Sore muscles
  • Joint discomfort
  • Arthritis

Warnings

  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame

Do Not Use

  • With heating pad or device
  • With creams, ointments, sprays or liniments
  • On wounds, damaged skin or irritated skin

Ask A Doctor Before Use If You

  • Have sensitive skin
  • Are pregnant or breastfeeding

When Using This Product

  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
  • Irritation develops

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/Children 2 Years And Older:

  • Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes

Children Under 2 Years Old:

  • Application should be supervised by an adult.

Other Information

  • Replace cap after use
  • Store in a cool, dry place.

Inactive Ingredient

Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine.

MADE IN USA for Healer Health LLC

Zionsville, Indiana 46077 TM Reg'd 85140-L

ICYFREEZE.COM

Package Label.Principal Display Panel

Principal Display Panel - Icy Freeze 3oz Gel Pump

FREEZES PAIN

THERAPUTIC PAIN RELIEF

Greaseless and stain free with Aloe, Vitamin E and Ilex

NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT

ICY FREEZE

COOLING PAIN RELIEF

FOR TENDONITIS, ARTHRITIS, SPRAINS AND STRAINS

GEL

4 FL OZ (120 mL)

Principal Display Panel (Icy Freeze 3oz Gel Pump)

Principal Display Panel (Icy Freeze 3oz Gel Pump)

Principal Display Panel - Icy Freeze 3oz Roll On

FREEZES PAIN

THERAPUTIC PAIN RELIEF

Greaseless and stain free with Aloe, Vitamin E and Ilex

NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT

ICY FREEZE

COOLING PAIN RELIEF

FOR TENDONITIS, ARTHRITIS, SPRAINS AND STRAINS

ROLL-ON

3 FL OZ (90 mL)

Principal Display Panel (Icy Freeze 3oz Roll On)

Principal Display Panel (Icy Freeze 3oz Roll On)

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