Budpak Medicated Anti Itch
FDA Label NDC 27293-027

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Budpak Inc. for the product Budpak Medicated Anti Itch (NDC 27293-027). 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, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, 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

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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