Ice Quake Analgesic Cream White
FDA Label NDC 69822-300

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 Analgesic Cream White (NDC 69822-300). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Methyl Salicylate 8%

Menthol 2%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

  • arthritis
  • simple backache
  • bruises
  • strains
  • sprains

Warnings

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

When Using This Product

  • use only as directed
  • Avoid contact with eyes and mucous membranes
  • do not bandage tightly or use with a heating devices
  • do not apply to wounds or damaged skin
  • Do not apply to irritated skin

Stop Use And Ask A Doctor If

  • condition worsens
  • redness is present
  • irritation develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center Immediately.

Directions

Adults and Children 12 Years of Age or Older

  • Apply generously to affected area
  • Massage into painfil area until thoroughly absorbed into skin
  • Repeat as necessary, but no more than 3 to 4 times daily

Inactive Ingredient

Mineral oil, Propylene glycol, Cetyl stearyl alcohol, Purified water, Ceteareth-6, Stearyl alcohol, PEG-20 Cetyl/Stearyl Ether, Methylparaben, propylparaben.

Package Label.Principal Display Panel

Analgesic Cream White

MENTHOL 2%, METHYL SALICYLATE 8%

NET WT 2 OZ (60 g)

Store: At Room Temperature 15° - 30°C (59°- 86°F). Close cap tightly after use.

Ice Quake White (Icequakewhite)

Ice Quake White (Icequakewhite)


Distribute By: SSS group, LLC

Pembroke Pines, FL 33332

Questions or Commnets?

Call 800.213.9370

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