BLISTEX LIP MEDEX (petrolatum, menthol, unspecified form, camphor- synthetic, and phenol paste

Blistex Lip Medex by

Drug Labeling and Warnings

Blistex Lip Medex 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
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

• for the temporary relief of pain and itching associated with minor lip irritation
• temporarily protects and helps relieve chapped or cracked lips
• helps protect lips from the drying effects of wind and cold weather

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

• 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 doctor

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)

INGREDIENTS AND APPEARANCE

BLISTEX LIP MEDEX 
petrolatum, 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	59.14 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 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)	PHENOL	0.6 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
1	NDC: 10157-8407-1	1 in 1 BLISTER PACK	03/28/2017
1		7.08 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 10157-8407-2	1 in 1 BLISTER PACK	03/28/2017
2		10.75 g in 1 JAR; 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	03/28/2017

Labeler - Blistex Inc. (005126354)

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