BLISTEX LIP MEDEX- petrolatum, menthol, unspecified form, camphor (synthetic), and phenol paste 
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® Lip Medex®

Drug Facts

Active ingredientsPurpose
Camphor 1.0% (w/w)External analgesic
Menthol 1.0% (w/w)External analgesic
Petrolatum 59.14% (w/w)Lip protectant
Phenol 0.54% (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

beeswax, benzyl alcohol, diisopropyl adipate, flavors, fragrances, lanolin, menthoxypropanediol, microcrystalline wax, myristyl myristate, ricinus communis (castor) seed oil, saccharin, theobroma cacao (cocoa) seed butter

PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack

NDC 10157-8407-1

Blistex®

LIP PROTECTANT/
EXTERNAL ANALGESIC

LIP MEDEX®

Relieves Sore Lips &
Restores Moisture Balance

Quickly Cools & Comforts

NET WT. .25 oz (7.08g)

PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack
BLISTEX LIP MEDEX 
petrolatum, menthol, unspecified form, camphor (synthetic), and phenol paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-8407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM59.14 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1 g  in 100 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
COCOA BUTTER (UNII: 512OYT1CRR)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CASTOR OIL (UNII: D5340Y2I9G)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)  
SACCHARIN (UNII: FST467XS7D)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CLOVE OIL (UNII: 578389D6D0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-8407-11 in 1 BLISTER PACK03/28/2017
17.08 g in 1 JAR; Type 0: Not a Combination Product
2NDC:10157-8407-21 in 1 BLISTER PACK03/28/2017
210.75 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/28/2017
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-8407)

Revised: 3/2017
Document Id: 8cf7754f-d295-46c3-80c6-5c023e7abbcd
Set id: 8ad39005-9419-4f1a-a1ae-2f76d212455e
Version: 1
Effective Time: 20170330
 
Blistex Inc.