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Blistex

Blistex Inc.

Blistex Foille Medicated First Aid Ointment


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Benzocaine 5.0% (w/w) External Analgesic
Chloroxylenol 0.1% (w/w) Antiseptic

Blistex Uses

  • For the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
  • First aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

  • For external use only.

When using this product

  • Avoid contact with the eyes

Stop use and ask a doctor if

  • condition worsens, or 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. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the affected area.
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a physician.

Blistex Other information

  • Avoid contact with clothing. Foille may stain certain fabrics.

Inactive ingredients

beeswax, benzyl alcohol, calcium disodium EDTA, calcium hydroxide, ceresin, eugenol, hydrogenated vegetable oil, maleic anhydride, mono- and di-glycerides, PEG-32, purified water, sodium borate, sodium lauryl sulfate, zea mays (corn) oil.

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC 10157-9302-4

Foille ®
EXTERNAL ANALGESIC / ANTISEPTIC

MEDICATED
FIRST AID OINTMENT

Fast, Soothing Relief Of Pain Due To:
Cuts & Scrapes • Minor Burns
Sunburn • Insect Bites

NET WT.
1 oz (28g)

Blistex

Blistex

Benzocaine and Chloroxylenol OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10157-9302
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 5 g
Chloroxylenol Chloroxylenol 0.1 g

Inactive Ingredients

Ingredient Name Strength
YELLOW WAX
BENZYL ALCOHOL
EDETATE CALCIUM DISODIUM ANHYDROUS
Calcium Hydroxide
Ceresin
Eugenol
MALEIC ANHYDRIDE
POLYETHYLENE GLYCOL 1500
water
SODIUM BORATE
SODIUM LAURYL SULFATE
CORN OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28 in 1 TUBE
2 NDC:10157-9302-4 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-03-05


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Be sure to consult your doctor before taking any medication!
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