Ice Quake Roll On
FDA Label NDC 69822-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Service, Inc. for the product Ice Quake Roll On (NDC 69822-102). 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 this and all medicine out of reach of children, warnings, stop use, uses, dosage & administration, purpose, 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 This And All Medicine Out Of Reach Of Children

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

Warnings

For the external use only. Use only as directed.

  • 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.

Stop Use

  • 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.in.

Uses

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 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 at room temperaturewith cap closed tightly.

Distribute by:

SSS Group, LLC.

Pembroke Pines, FL 33332

www.icequakeonline.com

Questions Or Comments?

1 800.213.9370

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