BLISTEX MEDICATED (dimethicone, camphor- synthetic, menthol, and phenol ointment

Blistex by

Drug Labeling and Warnings

Blistex 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 0.5% (w/w)	External analgesic
Dimethicone 1.1% (w/w)	Lip protectant
Menthol 0.6% (w/w)	External analgesic
Phenol 0.5% (w/w)	External analgesic

Uses

• for the temporary relief of pain and itching associated with minor lip irritation or cold sores
• temporarily protects and helps relieve chapped or cracked lips

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

allantoin, ammonium hydroxide, beeswax, calcium disodium EDTA, calcium hydroxide, cetyl alcohol, flavors, glycerin, hydrated silica, lanolin, lauric acid, mineral oil, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, polyglyceryl-3 diisostearate, potassium hydroxide, purified water, SD alcohol 36, sodium hydroxide, sodium saccharin, stearyl alcohol

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

NDC: 10157-9951-2

Blistex®

MEDICATED
LIP OINTMENT

LIP PROTECTANT/
EXTERNAL ANALGESIC

NET WT..21oz(6g)

Helps Heal Severe Dryness And Relieve Cold Sores

INGREDIENTS AND APPEARANCE

BLISTEX   MEDICATED
dimethicone, camphor (synthetic), menthol, and phenol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9951
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 (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET)	Camphor (synthetic)	0.5 g  in 100 g
Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A)	Menthol, unspecified form	0.625 g  in 100 g
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV)	Phenol	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
allantoin (UNII: 344S277G0Z)
ammonia (UNII: 5138Q19F1X)
yellow wax (UNII: 2ZA36H0S2V)
edetate calcium disodium anhydrous (UNII: 8U5D034955)
calcium hydroxide (UNII: PF5DZW74VN)
cetyl alcohol (UNII: 936JST6JCN)
glycerin (UNII: PDC6A3C0OX)
hydrated silica (UNII: Y6O7T4G8P9)
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)
saccharin sodium (UNII: SB8ZUX40TY)
stearyl alcohol (UNII: 2KR89I4H1Y)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9951-1	6 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2000
2	NDC: 10157-9951-3	10 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2000
3	NDC: 10157-9951-4	2.25 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2000
4	NDC: 10157-9951-5	8 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2000
5	NDC: 10157-9951-2	1 in 1 CARTON	12/01/2000
5	NDC: 10157-9951-6	6 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 10157-9951-7	3 in 1 CARTON	12/01/2000
6		6 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 10157-9951-8	4 in 1 CARTON	12/01/2000
7		6 g in 1 TUBE; 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	12/01/2000

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9951)