Xtracare Ice Cold Topical Analgesic Gel
FDA Label NDC 57337-052

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare Ice Cold Topical Analgesic Gel (NDC 57337-052). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:                                 Purpose

Menthol 1.25% ........................... Topical Analgesic

Otc - Purpose

Uses

for the temporary relief of minor aches and pains of muscles and joints.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Indications & Usage

XtraCare® Ice Cold Topical Analgesic Gel

Net Wt 8 oz (227 g)

Warnings

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

    • When using this product do not

    • heat
    • microwave
    • add to hot water or any container where heating water may cause splattering and result in burns
    • use in eyes or directly on mucous membranes
    • take by mouth or place in nostrils
    • apply to wounds or damaged skin
    • bandage skin

      • Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

Dosage & Administration

Directions

  • see important warnings under "When using this product"
  • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: consult a physician

Inactive Ingredient

Inactive Ingredients:

camphor, carbomer, ethyl alcohol, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

Other Safety Information

Other information: store at 20o to 25oC (68o to 77oF)

Questions/Comments? 1-855-345-5575

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

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