Ice Quake Muscle Rub Blue Gel
FDA Label NDC 69822-104

11 label sections · Submitted to the FDA by Southern Sales & Service, Inc. · 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 Muscle Rub Blue (NDC 69822-104). 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, purpoose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeing,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 2.0%

Purpoose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only. Avoid contact with eyes.

When Using This Product

  • do not bandage tightly
  • do not apply to wounds or damaged skin

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast-Feeing,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age and older:

consult a doctor. Children under 2 years of age:

Other Information

  • do not freeze
  • Keep lid tightly closed

Inactive Ingredients

carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanolamine, FD&C Blue #1, purified water.

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