LIP MEDEX LIP BALM (petrolatum, camphor- synthetic, menthol, unspecified form, and phenol stick

Lip Medex Lip Balm by

Drug Labeling and Warnings

Lip Medex Lip Balm 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 42% (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, cetyl alcohol, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, fragrance, isopropyl myristate, lanolin, menthoxypropanediol, menthyl lactate, methyl salicylate, microcrystalline wax, octyldodecanol, ozokerite, phenyl trimethicone, polyethylene, ricinus communis (castor) seed oil, saccharin, sorbitan isostearate, theobroma cacao (cocoa) seed butter, trimethylolpropane tricaprylate/tricaprate

PRINCIPAL DISPLAY PANEL - 4.25 g Stick Carton

Blistex®
NEW

DERMATOLOGIST RECOMMENDED

LIP MEDEX®

LIP PROTECTANT/EXTERNAL ANALGESIC

Delivers Instant Moisturization & Helps
Prevent Future Dryness

Quickly Cools & Comforts Dry, Sore Lips

3 Pack

3 Sticks Net Wt. 0.15 oz. (4.25 g) Ea.

INGREDIENTS AND APPEARANCE

LIP MEDEX LIP BALM 
petrolatum, camphor (synthetic), menthol, unspecified form, and phenol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1194
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	42 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	0.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
LANOLIN (UNII: 7EV65EAW6H)
OCTYLDODECANOL (UNII: 461N1O614Y)
TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)
YELLOW WAX (UNII: 2ZA36H0S2V)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
COCOA BUTTER (UNII: 512OYT1CRR)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CASTOR OIL (UNII: D5340Y2I9G)
SACCHARIN (UNII: FST467XS7D)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1194-1	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2024
2	NDC: 10157-1194-3	3 in 1 CARTON	07/01/2024
2		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	07/01/2024

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-1194)