BLISTEX  FOILLE MEDICATED FIRST AID- benzocaine and chloroxylenol ointment 
Blistex Inc.

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.

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Blistex®
Foille® Medicated First Aid Ointment

Drug Facts

Active ingredientsPurpose
Benzocaine 5.0 % (w/w)External analgesic
Chloroxylenol 0.1 % (w/w)Antiseptic

Uses

Warnings

For external use only

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.

  • 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

Other information

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

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)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
BLISTEX   FOILLE MEDICATED FIRST AID
benzocaine and chloroxylenol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine5 g  in 100 g
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
corn oil (UNII: 8470G57WFM)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
yellow wax (UNII: 2ZA36H0S2V)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
water (UNII: 059QF0KO0R)  
benzyl alcohol (UNII: LKG8494WBH)  
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
ceresin (UNII: Q1LS2UJO3A)  
sodium borate (UNII: 91MBZ8H3QO)  
calcium hydroxide (UNII: PF5DZW74VN)  
edetate calcium disodium anhydrous (UNII: 8U5D034955)  
eugenol (UNII: 3T8H1794QW)  
sodium lauryl sulfate (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9302-41 in 1 CARTON03/05/2013
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10157-9302-31 in 1 CARTON09/23/2016
214 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/05/2013
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9302)

Revised: 12/2021
Document Id: 3722476b-f75e-43af-b09b-afe4c28857fb
Set id: e2eca808-e97b-43e0-aa51-7025cc61c7a8
Version: 3
Effective Time: 20211214
 
Blistex Inc.