Label: BUDPAK FIRST AID- lidocaine hcl and phenol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 12, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT
    Active Ingredients - Lidocaine HCl 0.5% Phenol 0.5%
  • PURPOSE
    Purpose - Topical Anesthetic - Antiseptic
  • INDICATIONS & USAGE
    Uses - first aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.
  • WARNINGS
    Warnings - For external use only
  • DO NOT USE
    Do not use in eyes, do not apply over large areas of the body. In case of deep puncture wounds or serious burns, consult a doctor.
  • STOP USE
    Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases or if infection develops.
  • 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 - Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with sterile ...
  • SPL UNCLASSIFIED SECTION
    Other Information - Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF). Lot No. & Exp. Date: see crimp of tube.
  • INACTIVE INGREDIENT
    Inactive Ingredients - Purified Water, Mineral Oil, Petrolatum, Cetearyl Alcohol, Glyceryl Stearate, Propylene Glycol, Stearic Acid, Methylparaben, Sorbitan Stearate,  Polysorbate 60 ...
  • SPL UNCLASSIFIED SECTION
    PRINCIPAL DISPLAY PANEL - Budpak First Aid Cream - Lidocaine HCl 0.5% Phenol 0.5% NET WT 1 OZ (28 g)
  • PRINCIPAL DISPLAY PANEL
    image of package label
  • INGREDIENTS AND APPEARANCE
    Product Information
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!