BLISTEX LIP- dimethicone, camphor, menthol, phenol ointment

Blistex Lip by

Drug Labeling and Warnings

Blistex Lip by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Dimethicone 1.1% (w/w)

Camphor 0.5% (w/w)

Menthol 0.6% (w/w)

Phenol 0.5% (w/w)

PURPOSE

Purpose:

Skin protectant

External analgesic

External analgesic

External analgesic

INDICATIONS & USAGE

Uses: for the temporary protection and relief of pain and itching associated with

• minor lip irritation
• chapped or cracked lips
• cold sores

WARNINGS

Warnings: For external use only

DO NOT USE

Do not use

• in the eyes or over large portions of the body
• on deep or puncture wounds
• on animal bites
• on serious burns

STOP USE

Stop use and ask a doctor if

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

DOSAGE & ADMINISTRATION

Directions

Adults and children 2 years of age and over: apply liberally to affected area not more than 3 to 4 times daily

Children under 2 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Allontoin, Ammonium Hydroxide, Beeswax, Calcium Disodium EDTA, Calcium Hydroxide, Cetyl Alcohol, Flavors, Glycerin, Lanolin, Lauric Acid, Mineral Oil, Myristic Acid, Oleic Acid, Palmitic Acid, Paraffin, Petrolatum, Polyglyceryl-3 diisostearate, Potassium Hydroxide, Purified Water, SD Alcohol 36, Silica, Sodium Hydroxide, Sodium Saccharin, Stearyl Alcohol

PRINCIPAL DISPLAY PANEL

Blistex.jpg

INGREDIENTS AND APPEARANCE

BLISTEX LIP 
dimethicone, camphor, menthol, phenol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.1 g  in 100 g
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.6 g  in 100 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
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)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0029-2	25 in 1 BOX, UNIT-DOSE
1		.5 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/09/1995

Labeler - HART Health (069560969)