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  5. Label Information: Family Care Maximum Strength Medicated Anti Itch

FDA Label for Family Care Maximum Strength Medicated Anti Itch

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - WHEN USING
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. INDICATIONS & USAGE
    8. STORAGE AND HANDLING
    9. INACTIVE INGREDIENT
    10. DOSAGE & ADMINISTRATION
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Family Care Maximum Strength Medicated Anti Itch Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange 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%..................................................................................Anti-itch, Pain Relief

Pramoxine Hydrochloride 1%.........................................................Anti-itch, Pain Relief


Otc - Purpose



Uses For temporary relief of pain and itch associated with:

  • minor skin irritations
  • minor cuts
  • minor burns
  • minor sunburns
  • rashes due to poison ivy, oak, or sumac
  • insect bites
  • scrapes

Warnings



Warnings For external use only.


Otc - When Using



When using this product avoid contact with eyes


Otc - Stop Use



Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.


Otc - Keep Out Of Reach Of Children



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


Indications & Usage



Directions

  • Adults and children 2 years and older apply freely to affected area 3 to 4 times daily.
  • Children under 2 years: consult a doctor.

Storage And Handling



Other information

  • Store between 20°C and 25°C (68°F and 77°F)
  • Lot No. and Exp Date: see box or see crimp of tube

Inactive Ingredient



Inactive ingredients aloe vera leaf, carbomer 940, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, methyl salicylate, mineral oil, polysorbate 60, propylparaben, stearyl alcohol, tocopheryl acetate, trolamine, water


Dosage & Administration



Distributed By:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea


* Please review the disclaimer below.