BLISTEX FOILLE MEDICATED FIRST AID- benzocaine and chloroxylenol ointment

Blistex by

Drug Labeling and Warnings

Blistex by is a Otc medication manufactured, distributed, or labeled by Blistex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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.

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)

INGREDIENTS AND APPEARANCE

BLISTEX   FOILLE MEDICATED FIRST AID
benzocaine and chloroxylenol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	5 g  in 100 g
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q)	Chloroxylenol	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
yellow wax (UNII: 2ZA36H0S2V)
benzyl alcohol (UNII: LKG8494WBH)
edetate calcium disodium anhydrous (UNII: 8U5D034955)
calcium hydroxide (UNII: PF5DZW74VN)
ceresin (UNII: Q1LS2UJO3A)
eugenol (UNII: 3T8H1794QW)
maleic anhydride (UNII: V5877ZJZ25)
polyethylene glycol 1500 (UNII: 1212Z7S33A)
water (UNII: 059QF0KO0R)
sodium borate (UNII: 91MBZ8H3QO)
sodium lauryl sulfate (UNII: 368GB5141J)
corn oil (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9302-4	1 in 1 CARTON	03/05/2013
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10157-9302-3	1 in 1 CARTON	09/23/2016
2		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	03/05/2013

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9302)