Frozen Ice Fast Pain Relief
FDA Label NDC 53113-363

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gadal Laboratories, Inc for the product Frozen Ice Fast Pain Relief (NDC 53113-363). 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 ingredient, inactive ingredient, keep out of reach of children, warnings, indications & usage, dosage & administration, purpose, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active IngredientsPurpose
Menthol 3.5%Topical Analgesic
Camphor 0.2%Topical Analgesic

Inactive Ingredient

Carbomer, Propylene Glycol, Methylparaben, Isopropyl Alcohol, Triethanolamine, FD&C Blue #1, Purified Water.

Keep Out Of Reach Of Children

KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN

Warnings

For the external use only. Use only as directed.

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occurs again within a few days, discontinue use of this product and consults a doctor.
  • Avoid contact with eyes.
  • Do not use with other topical products.
  • Do not use with heating device.
  • Do not apply to open wounds or damaged skin.

    • In case of accidental ingestion, seek professional help and contact a Poison Control Center immediately.

Indications & Usage

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

Dosage & Administration

Adults and children 12 years of age and older.
Apply to painful muscles and joints.
Gently massage thoroughly into affected area.
Repeat as necessary but no more than 4 times daily

Purpose

Topical Analgesic

Other Information:

Store in cool, dry location at room temperature 59°- 86°F (15° - 30°C) with cao closed tightly. Keep away from excessive heat or open flame.

Manufactured by:

GABAL Laboratories, Inc.

Miami, FL 33186 – (305)382-3288

www.gadallaboratories.com

MADE IN USA

* Please review the disclaimer below.