Blistex®

Blistex®
SPL v4
SPL
SPL Set ID e2eca808-e97b-43e0-aa51-7025cc61c7a8
Route
TOPICAL
Published
Effective Date 2024-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (5 g) Chloroxylenol (0.1 g)
Inactive Ingredients
Corn Oil Hydrogenated Coconut Oil Yellow Wax Polyethylene Glycol 1600 Water Benzyl Alcohol Glyceryl Mono- And Dipalmitostearate Ceresin Sodium Borate Calcium Hydroxide Edetate Calcium Disodium Anhydrous Eugenol Sodium Lauryl Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-05

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
  • First aid to help prevent infection in minor cuts, scrapes and burns.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50570-1
  • Do not apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
Section 55105-1
Active ingredients Purpose
Benzocaine 5.0 % (w/w) External analgesic
Chloroxylenol 0.1 % (w/w) Antiseptic
Warnings

For external use only

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.
Other Information
  • Avoid contact with clothing. Foille may stain certain fabrics.
Inactive Ingredients

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

When Using This Product
  • Avoid contact with the eyes
Stop Use and Ask A Doctor If
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
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:

Minor Cuts, Scrapes & Burns

Sunburn • Insect Bites

Net Wt.

1 oz. (28 g)


Structured Label Content

Uses
  • For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
  • First aid to help prevent infection in minor cuts, scrapes and burns.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50570-1 (50570-1)
  • Do not apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
Section 55105-1 (55105-1)
Active ingredients Purpose
Benzocaine 5.0 % (w/w) External analgesic
Chloroxylenol 0.1 % (w/w) Antiseptic
Warnings

For external use only

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.
Other Information (Other information)
  • Avoid contact with clothing. Foille may stain certain fabrics.
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)
  • Avoid contact with the eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Principal Display Panel 28 G Tube Carton (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:

Minor Cuts, Scrapes & Burns

Sunburn • Insect Bites

Net Wt.

1 oz. (28 g)


Advanced Ingredient Data


Raw Label Data

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