NDC Code(s) : 10157-8407-1, 10157-8407-2, 10157-8407-3, 10157-8407-4, 10157-8407-5
Packager : Blistex Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), and PHENOL PASTE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-8407
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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 Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1NDC:10157-8407-11 in 1 BLISTER PACK 28/03/2017
17.08 g in 1 JAR Type 0: Not a Combination Product
2NDC:10157-8407-21 in 1 BLISTER PACK 28/03/2017
210.75 g in 1 JAR Type 0: Not a Combination Product
3NDC:10157-8407-33 in 1 BLISTER PACK 29/11/2022
37.08 g in 1 JAR Type 0: Not a Combination Product
4NDC:10157-8407-47.08 g in 1 JAR Type 0: Not a Combination Product24/01/2024
5NDC:10157-8407-510.75 g in 1 JAR Type 0: Not a Combination Product24/01/2024
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph drug M017 03/28/2017

LABELER - Blistex Inc.(005126354)

Establishment
Name Address ID/FEI Business Operations
Blistex Inc. 005126354 MANUFACTURE(10157-8407)

PRINCIPAL DISPLAY PANEL

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