NDC 10157-9910 Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip)

Dimethicone, Octinoxate, Octisalate, Camphor (synthetic), Menthol, Unspecified Form, And Phenol

NDC Product Code 10157-9910

NDC CODE: 10157-9910

Proprietary Name: Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dimethicone, Octinoxate, Octisalate, Camphor (synthetic), Menthol, Unspecified Form, And Phenol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 10157 - Blistex Inc
    • 10157-9910 - Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip)

NDC 10157-9910-1

Package Description: 1 KIT in 1 CARTON * 4.25 g in 1 CYLINDER * 6 g in 1 TUBE * 4.25 g in 1 CYLINDER

NDC Product Information

Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) with NDC 10157-9910 is a a human over the counter drug product labeled by Blistex Inc. The generic name of Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) is dimethicone, octinoxate, octisalate, camphor (synthetic), menthol, unspecified form, and phenol. The product's dosage form is kit and is administered via form.

Labeler Name: Blistex Inc

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C RED NO. 6 (UNII: 481744AI4O)
  • 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)
  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Blistex Inc
Labeler Code: 10157
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-03-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) Product Label Images

Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

MEDICATED BERRY BALMDrug Facts

For external use only

MEDICATED LIP BALMDrug Facts

For external use only

MEDICATED LIP OINTMENTDrug Facts

Otc - Purpose

Active ingredientsPurposeDimethicone 2.0% (w/w)Lip protectantOctinoxate 6.6% (w/w)SunscreenOctisalate 4.4% (w/w)Sunscreen

Active ingredientsPurposeDimethicone 2.0 % (w/w)Lip protectantOctinoxate 6.6 % (w/w)SunscreenOctisalate 4.4 % (w/w)Sunscreen

Active ingredientsPurposeCamphor 0.5% (w/w)External analgesicDimethicone 1.1% (w/w)Lip protectantMenthol 0.625% (w/w)External analgesicPhenol 0.5% (w/w)External analgesic

Uses

  • Temporarily protects and helps relieve chapped or cracked lipshelps prevent sunburn

  • Temporarily protects and helps relieve chapped or cracked lipshelps prevent sunburn

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

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.

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.

Otc - Do Not Use

Do not use on damaged or broken skin

Do not use on damaged or broken skin

Otc - When Using

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

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Stop use and ask a doctor if rash occurs

Otc - 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.

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

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 exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingchildren under 6 months of age: Ask a doctor

  • Apply liberally 15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingchildren under 6 months of age: Ask a doctor

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: Consult a doctor

Other Information

  • Protect the product in this container from excessive heat and direct sun

  • 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

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

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

Warnings

For external use only

Do Not Use On

  • Deep or puncture woundsanimal bitesserious burns

When Using This Product

  • Do not get into eyesdo not apply over large areas of the body or bandage

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days

* Please review the disclaimer below.