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  5. Label Information: Ice Cold Analgesic

FDA Label for Ice Cold Analgesic

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. DOSAGE & ADMINISTRATION
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ice Cold Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Volume Distributors, Inc.. 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 Ingredient                   Purpose

Menthol 1.0% ............. Topical Analgesic


Otc - Purpose



Uses temporarily relieves:

  • minor muscle aches and pains

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



DT for your DailyTouch

Ice Cold Analgesic Gel

Gel Frio Antimuscular


Dosage & Administration



Directions

For the temporary relief of minor muscle aches and pains.

See important warnings under "When using this product"

  • not for use on children under 2 years of age
  • adults & children 2 years & older: apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.

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 healing water may cause splattering and result in burns
    • use in eyes or directly on mucous membranes
    • take my 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.


Inactive Ingredient



Inactive Ingredients

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


Package Label.Principal Display Panel



image description - label

image description - label


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