Budpak Feminine Anti-itch
FDA Label NDC 27293-022

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 Feminine Anti-itch (NDC 27293-022). 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 - stop use, otc - keep out of reach of children, dosage & administration, other, 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

Benzocaine 5%

Resorcinol 2%

Otc - Purpose

Purpose

External analgesic

Indications & Usage

Uses

  • temporarily relieves itching

Warnings

Warnings

For external use only

Avoid contact with eyes

Otc - Stop Use

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

Do not apply over large areas of the body.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Dosage & Administration

Directions

Adults and children, 2 years and older:

  • Apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.

    • Children under 2 years of age: Consult a doctor

Other

Other information

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

    • PRINCIPAL DISPLAY PANEL

    Budpak Feminine Anti-Itch Cream

    Benzocaine 5%

    Resorcinol 2%

    External analgesic

    NET WT 0.75 OZ (21.2 g)

Inactive Ingredient

Inactive Ingredients

Purified water, cetyl alcohol, glyceryl stearate, PEG-100 stearate, mineral oil, isopropyl palmitate, aloe barbadensis leaf juice, alpha tocopherol acetate, corn oil, cholecalciferol, methyl paraben, isopropyl myristate, sodium sulfite, trolamine, trisodium HEDTA, vitamin A palmitate, carbomer homopolymer type c.

Package Label.Principal Display Panel

Image Of Package Label (Feminine Anti Itch)

Image Of Package Label (Feminine Anti Itch)

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