BLISTEX MEDICATED VARIETY PACK (BLISTEX MEDICATED BERRY LIP BALM, BLISTEX MEDICATED LIP BALM, BLISTEX MEDICATED LIP)- dimethicone, padimate o, oxybenzone, octinoxate, octisalate, camphor (synthetic), menthol, unspecified form, and phenol
Blistex Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Blistex® Medicated Variety Pack (Blistex® Medicated Berry Lip Balm, Blistex® Medicated Lip Balm, Blistex® Medicated Lip Ointment)

MEDICATED BERRY BALM

Drug Facts

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

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

MEDICATED LIP BALM

Drug Facts

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

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

MEDICATED LIP OINTMENT

Drug Facts

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 - Kit Carton

Blistex® MEDICATED VARIETY PACK

Helps heal, soothe
& protect

There's No Bliss Like Blistex®

BLISTEX MEDICATED VARIETY PACK (BLISTEX MEDICATED BERRY LIP BALM, BLISTEX MEDICATED LIP BALM, BLISTEX MEDICATED LIP)
dimethicone, padimate o, oxybenzone, octinoxate, octisalate, camphor (synthetic), menthol, unspecified form, and phenol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-9901

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10157-9901-1	1 in 1 CARTON	11/20/2018	01/30/2020

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

Part 1 of 3

BLISTEX MEDICATED BERRY LIP BALM
dimethicone, padimate o, and oxybenzone 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
Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ)	Padimate O	6.6 g in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
yellow wax (UNII: 2ZA36H0S2V)
cetyl alcohol (UNII: 936JST6JCN)
cetyl palmitate (UNII: 5ZA2S6B08X)
candelilla wax (UNII: WL0328HX19)
isopropyl myristate (UNII: 0RE8K4LNJS)
isopropyl palmitate (UNII: 8CRQ2TH63M)
isopropyl stearate (UNII: 43253ZW1MZ)
lanolin (UNII: 7EV65EAW6H)
lanolin oil (UNII: OVV5IIJ58F)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
petrolatum (UNII: 4T6H12BN9U)
propylparaben (UNII: Z8IX2SC1OH)
D&C red no. 6 (UNII: 481744AI4O)
aluminum oxide (UNII: LMI26O6933)
cocoa butter (UNII: 512OYT1CRR)
titanium dioxide (UNII: 15FIX9V2JP)

#	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	01/30/2020

Part 2 of 3

BLISTEX MEDICATED LIP BALM
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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
LANOLIN OIL (UNII: OVV5IIJ58F)
YELLOW WAX (UNII: 2ZA36H0S2V)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETYL ALCOHOL (UNII: 936JST6JCN)
PARAFFIN (UNII: I9O0E3H2ZE)
COCOA BUTTER (UNII: 512OYT1CRR)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O)
METHYL SALICYLATE (UNII: LAV5U5022Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 6 (UNII: 481744AI4O)

#	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	01/30/2020

Part 3 of 3

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	01/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	11/20/2018	01/30/2020

Labeler - Blistex Inc (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc		005126354	MANUFACTURE(10157-9901)

Revised: 1/2020

Document Id: 5670a3a0-d331-4364-aa3a-c3b11f08d82e

Set id: 0e4da147-5c1b-4371-a42d-92ca2236e304

Version: 2

Effective Time: 20200131

Blistex Inc