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  5. Label Information: Budpak Medicated Anti Itch

FDA Label for Budpak Medicated Anti Itch

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. OTHER
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Budpak Medicated Anti Itch Product Label

The following document was submitted to the FDA by the labeler of this product Budpak 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 Ingredients

Camphor 1%
Menthol 1%


Otc - Purpose



Purpose

External anti-infective and anesthetic

Anti itch pain relief


Indications & Usage



Uses

For the temporary relief of pain and itching associated with:

  • minor skin irritation
  • allergic itches
  • rashes
  • hives
  • minor burns
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use on children under 2 years of age.

  • avoid contact with eyes
  • do not apply to open wound or damaged skin.

Otc - Stop Use



Stop use and ask a doctor

  • if condition worsens
  • symptoms persist for 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

  • For children under 2 years of age: consult a physician.


Other



Other information

  • Store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • Lot No. & Exp. Date: see crimp of tube.

    • PRINCIPAL DISPLAY PANEL

    Budpak Medicated Anti-Itch Cream

    Camphor 1%

    Menthol 1%

    NET WT 1 OZ (28 g)


Inactive Ingredient



Inactive ingredients

Purified Water, Petrolatum, Cetearyl Alcohol, Glycerin, Mineral Oil, Steareth-21, Glyceryl Stearate, Steareth-2, Alcohol, Carbomer, Triethanolamine, Methylparaben, Propylparaben, Aloe barbadensis leaf juice, Vitamin E.


Package Label.Principal Display Panel



image of package label - camphor menthol

image of package label - camphor menthol


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