Search by Drug Name or NDC

NDC 10157-9904-01 Blistex Complete Care (Blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, and Blistex Complete Moisture) Details

Blistex Complete Care (Blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, and Blistex Complete Moisture)

Blistex Complete Care (Blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, and Blistex Complete Moisture) is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc.. The primary component is .

Product Information

NDC	10157-9904
Product ID	10157-9904_cac1566d-e74f-4c9d-9bf3-25ae8086900d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Blistex Complete Care (Blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, and Blistex Complete Moisture)
Proprietary Name Suffix	n/a
Non-Proprietary Name	PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), PHENOL, Dimethicone, Avobenzone, Homosalate, Octinoxate, and Octisalate
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Blistex Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2022-12-31

Package

Package Images

NDC 10157-9904-01 (10157990401)

Pricing Information	N/A
NDC Package Code	10157-9904-1
Billing NDC	10157990401
Package	1 KIT in 1 BLISTER PACK (10157-9904-1) * 4.25 g in 1 CYLINDER * 4.25 g in 1 CYLINDER * 6 g in 1 TUBE * 7.08 g in 1 JAR
Marketing Start Date	2018-11-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ad45a5d1-0589-4857-ab39-9a02e15f3164 Details

SPL UNCLASSIFIED SECTION

LIP MEDEX®

Drug Facts

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

MEDICATED

LIP OINTMENT

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

SPL UNCLASSIFIED SECTION

FIVE STAR

LIP PROTECTION®

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Avobenzone 3.0% (w/w)	Sunscreen
Dimethicone 2.0% (w/w)	Lip protectant
Homosalate 10.0% (w/w)	Sunscreen
Octinoxate 7.5% (w/w)	Sunscreen
Octisalate 5.0% (w/w)	Sunscreen

Uses

temporarily protects and helps relieve chapped or cracked lips
helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

apply liberally 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months of age: Ask a doctor
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  - limit time in the sun, especially from 10 a.m.-2 p.m.
  - wear long sleeve shirts, pants, hats, and sunglasses

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, calendula officinalis flower extract, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla) wax, flavor, helianthus annuus (sunflower) seed oil, microcrystalline wax, myristyl myristate, octyldodecanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil

SPL UNCLASSIFIED SECTION

COMPLETE MOISTURE®

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Dimethicone 2.0% (w/w)	Lip protectant
Octinoxate 6.6% (w/w)	Sunscreen
Octisalate 4.4% (w/w)	Sunscreen

Uses

temporarily protects and helps relieve chapped or cracked lips
helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

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

Directions

apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

behenoyl stearic acid, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavor, glycerin, hydrogenated phosphatidylcholine, jojoba esters, microcrystalline wax, ozokerite, panthenol, petrolatum, phenoxyethanol, purified water, sodium borate, sodium saccharin, squalane

PRINCIPAL DISPLAY PANEL - Blister Pack Kit

Blistex®

COMPLETE MOISTURE & FIVE STAR: LIP PROTECTANT/SUNSCREEN

LIP OINTMENT & LIP MEDEX: LIP PROTECTANT/EXTERNAL ANALGESIC

PROTECT • MOISTURIZE • RELIEVE

BUY 3 GET 1 BONUS

1 Jar Net Wt. 0.25 oz (7.08 g)

1 Tube Net Wt. 0.21 oz. (6 g)

2 Sticks Net Wt. 0.15 oz.

(4.25 g) ea.

PRINCIPAL DISPLAY PANEL - Blister Pack Kit

INGREDIENTS AND APPEARANCE

BLISTEX COMPLETE CARE (BLISTEX LIP MEDEX, BLISTEX MEDICATED LIP, BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM, AND BLISTEX COMPLETE MOISTURE)

petrolatum, menthol, unspecified form, camphor (synthetic), phenol, dimethicone, avobenzone, homosalate, octinoxate, and octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-9904

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10157-9904-1	1 in 1 BLISTER PACK	11/20/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 JAR	7.08 g
Part 2	1 TUBE	6 g
Part 3	1 CYLINDER	4.25 g
Part 4	1 CYLINDER	4.25 g

Part 1 of 4
BLISTEX LIP MEDEX petrolatum, menthol, unspecified form, camphor (synthetic), and phenol paste

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		7.08 g in 1 JAR; 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	11/20/2018

Part 2 of 4
BLISTEX MEDICATED LIP dimethicone, camphor (synthetic), menthol, unspecified form, and phenol ointment

Product Information
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
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PARAFFIN (UNII: I9O0E3H2ZE)
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
PEPPERMINT OIL (UNII: AV092KU4JH)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PALMITIC ACID (UNII: 2V16EO95H1)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
LAURIC ACID (UNII: 1160N9NU9U)
MYRISTIC ACID (UNII: 0I3V7S25AW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
OLEIC ACID (UNII: 2UMI9U37CP)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		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	11/20/2018

Part 3 of 4
BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM dimethicone, avobenzone, homosalate, octinoxate, and octisalate stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	2 g in 100 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g in 100 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 g in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Microcrystalline Wax (UNII: XOF597Q3KY)
Octyldodecanol (UNII: 461N1O614Y)
Ceresin (UNII: Q1LS2UJO3A)
Myristyl Myristate (UNII: 4042ZC00DY)
Stearyl Behenate (UNII: A68S9UI39D)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
Bis-Diglyceryl Polyacyladipate-2 (UNII: 6L246LAM9T)
CANDELILLA WAX (UNII: WL0328HX19)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
WHEAT GERM OIL (UNII: 14C97E680P)
SAFFLOWER OIL (UNII: 65UEH262IS)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBIC ACID (UNII: X045WJ989B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PANTHENOL (UNII: WV9CM0O67Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/20/2018

Part 4 of 4
BLISTEX COMPLETE MOISTURE dimethicone, octinoxate, and octisalate stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.6 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
7-BEHENOYLSTEARIC ACID (UNII: P2T8BLD83C)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
SODIUM BORATE (UNII: 91MBZ8H3QO)
PANTHENOL (UNII: WV9CM0O67Z)
SQUALANE (UNII: GW89575KF9)
CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 07PS463G0H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/20/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/20/2018

Labeler - Blistex Inc. (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc.		005126354	MANUFACTURE(10157-9904)

Revised: 12/2018

Document Id: cac1566d-e74f-4c9d-9bf3-25ae8086900d

Set id: ad45a5d1-0589-4857-ab39-9a02e15f3164

Version: 1

Effective Time: 20181207

Search by Drug Name or NDC

NDC 10157-9904-01 Blistex Complete Care (Blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, and Blistex Complete Moisture) Details

Blistex Complete Care (Blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, and Blistex Complete Moisture)

Product Information

Package

Package Images

NDC 10157-9904-01 (10157990401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ad45a5d1-0589-4857-ab39-9a02e15f3164 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

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Skin Cancer/Skin Aging Alert

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL - Blister Pack Kit

INGREDIENTS AND APPEARANCE