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NDC 10157-9951-02 Blistex .5; 1.1; .625; .5 g/100g; g/100g; g/100g; g/100g Details

Blistex .5; 1.1; .625; .5 g/100g; g/100g; g/100g; g/100g

Blistex is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc.. The primary component is CAMPHOR (SYNTHETIC); DIMETHICONE; MENTHOL, UNSPECIFIED FORM; PHENOL.

Product Information

NDC	10157-9951
Product ID	10157-9951_9d89ac76-989e-43ee-9c2c-9da499cd4224
Associated GPIs	88502000004200
GCN Sequence Number	060256
GCN Sequence Number Description	menthol/camphor/dimeth/phenol OINT. (G) 0.6%-0.5% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	26367
HICL Sequence Number	033422
HICL Sequence Number Description	MENTHOL/CAMPHOR/DIMETHICONE/PHENOL
Brand/Generic	Brand
Proprietary Name	Blistex
Proprietary Name Suffix	Medicated
Non-Proprietary Name	Dimethicone, Camphor (synthetic), Menthol, and Phenol
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	.5; 1.1; .625; .5
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); DIMETHICONE; MENTHOL, UNSPECIFIED FORM; PHENOL
Labeler Name	Blistex Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10157-9951-02 (10157995102)

Pricing Information	N/A
NDC Package Code	10157-9951-2
Billing NDC	10157995102
Package	1 TUBE in 1 CARTON (10157-9951-2) / 6 g in 1 TUBE (10157-9951-6)
Marketing Start Date	2000-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e95439d3-f12b-4c1c-999a-79f2ddba4cfb Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Camphor 0.5% (w/w)	External analgesic
Dimethicone 1.1% (w/w)	Lip protectant
Menthol 0.625% (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

Penetrating

Medication

And Moisture

Blistex®

MEDICATED LIP OINTMENT

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	12/01/2000

Labeler - Blistex Inc. (005126354)

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

Revised: 12/2021

Document Id: 9d89ac76-989e-43ee-9c2c-9da499cd4224

Set id: e95439d3-f12b-4c1c-999a-79f2ddba4cfb

Version: 3

Effective Time: 20211217

Search by Drug Name or NDC

NDC 10157-9951-02 Blistex .5; 1.1; .625; .5 g/100g; g/100g; g/100g; g/100g Details

Blistex .5; 1.1; .625; .5 g/100g; g/100g; g/100g; g/100g

Product Information

Package

Package Images

NDC 10157-9951-02 (10157995102)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e95439d3-f12b-4c1c-999a-79f2ddba4cfb Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use on

When using this product

Stop use and ask a doctor if

Directions

Inactive ingredients

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

INGREDIENTS AND APPEARANCE

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