BLISTEX  MEDICATED- dimethicone, camphor (synthetic), menthol, and phenol 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®
Medicated Lip ointment

Drug Facts

Active ingredientsPurpose
Camphor 0.5% (w/w)External analgesic
Dimethicone 1.1% (w/w)Lip protectant
Menthol 0.625% (w/w)External analgesic
Phenol 0.5% (w/w)External analgesic

Uses

Warnings

For external use only

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not get into eyes
  • do not apply over large areas of the body or bandage

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

allantoin, ammonium hydroxide, beeswax, calcium disodium EDTA, calcium hydroxide, cetyl alcohol, flavors, glycerin, hydrated silica, lanolin, lauric acid, mineral oil, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, polyglyceryl-3 diisostearate, potassium hydroxide, purified water, SD alcohol 36, sodium hydroxide, sodium saccharin, stearyl alcohol

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

Penetrating
Medication
And Moisture

Blistex®
MEDICATED LIP OINTMENT

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton
BLISTEX   MEDICATED
dimethicone, camphor (synthetic), menthol, and phenol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9951
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1.1 g  in 100 g
Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET) Camphor (synthetic)0.5 g  in 100 g
Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A) Menthol, unspecified form0.625 g  in 100 g
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
allantoin (UNII: 344S277G0Z)  
ammonia (UNII: 5138Q19F1X)  
yellow wax (UNII: 2ZA36H0S2V)  
edetate calcium disodium anhydrous (UNII: 8U5D034955)  
calcium hydroxide (UNII: PF5DZW74VN)  
cetyl alcohol (UNII: 936JST6JCN)  
glycerin (UNII: PDC6A3C0OX)  
hydrated silica (UNII: Y6O7T4G8P9)  
lanolin (UNII: 7EV65EAW6H)  
lauric acid (UNII: 1160N9NU9U)  
mineral oil (UNII: T5L8T28FGP)  
myristic acid (UNII: 0I3V7S25AW)  
oleic acid (UNII: 2UMI9U37CP)  
palmitic acid (UNII: 2V16EO95H1)  
paraffin (UNII: I9O0E3H2ZE)  
petrolatum (UNII: 4T6H12BN9U)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
potassium hydroxide (UNII: WZH3C48M4T)  
water (UNII: 059QF0KO0R)  
sodium hydroxide (UNII: 55X04QC32I)  
saccharin sodium (UNII: SB8ZUX40TY)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9951-16 g in 1 TUBE; Type 0: Not a Combination Product12/01/2000
2NDC:10157-9951-310 g in 1 TUBE; Type 0: Not a Combination Product12/01/2000
3NDC:10157-9951-42.25 g in 1 TUBE; Type 0: Not a Combination Product12/01/2000
4NDC:10157-9951-58 g in 1 TUBE; Type 0: Not a Combination Product12/01/2000
5NDC:10157-9951-21 in 1 CARTON12/01/2000
5NDC:10157-9951-66 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:10157-9951-73 in 1 CARTON12/01/2000
66 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:10157-9951-84 in 1 CARTON12/01/2000
76 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 FINALpart34812/01/2000
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9951)

Revised: 12/2021
Document Id: 9d89ac76-989e-43ee-9c2c-9da499cd4224
Set id: e95439d3-f12b-4c1c-999a-79f2ddba4cfb
Version: 3
Effective Time: 20211217
 
Blistex Inc.