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  5. Label Information: Xtracare Ice Cold Topical Analgesic Gel

FDA Label for Xtracare Ice Cold Topical Analgesic Gel

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. OTHER SAFETY INFORMATION
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Xtracare Ice Cold Topical Analgesic Gel Product Label

The following document was submitted to the FDA by the labeler of this product China Ningbo Shangge Cosmetic Technology Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Package Label.Principal Display Panel




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