Icequake Analgestic White Cream
FDA Label NDC 69822-310

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 Icequake Analgestic White (NDC 69822-310). 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 drug facts, active ingredients, purpose, uses, warnings, when using this products, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Menthyl Salicylate 10%

Menthol 2%

Purpose

Topical Analgesic

Topical Analgesic

Uses

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

  • Arthritis
  • Simple backache
  • Strains
  • Sprains
  • Bruises

Warnings

For external use only

  • avoid contact with eyes and mucous membranes
  • do not use otherwise than as directed

    • Caution: Discontinue use if excessive irritation of the skin develops.

When Using This Products

  • 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-Feeding,

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

Audlts and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: consult a doctor.

Other Information

store at room temperature 15° - 30°C (59° - 86°F)

close cap tightly after use.

Inactive Ingredients

mineral oil, propylene gylcol, cetyl stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 cetyl/stearyl ether, methylparaben, propylparaben.

Icequake Topical Analgestic Cream White 60G

Label (Untitled)

Label (Untitled)

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