FDA Label for Budpak Feminine Anti-itch

View Indications, Usage & Precautions

Budpak Feminine 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

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




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