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
Blistex Inc.
Human Otc Drug
NDC 10157-9904Blistex Complete Care (blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, And Blistex Complete Moisture) also known as Petrolatum, Menthol, Unspecified Form, Camphor (synthetic), Phenol, Dimethicone, Avobenzone, Homosalate, Octinoxate, And Octisalate is a human otc drug labeled by 'Blistex Inc.'. National Drug Code (NDC) number for Blistex Complete Care (blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, And Blistex Complete Moisture) is 10157-9904. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Blistex Complete Care (blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, And Blistex Complete Moisture) drug includes . The currest status of Blistex Complete Care (blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, And Blistex Complete Moisture) drug is Active.
Drug Information:
| Drug NDC: | 10157-9904 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Blistex Complete Care (blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, And Blistex Complete Moisture) |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Petrolatum, Menthol, Unspecified Form, Camphor (synthetic), Phenol, Dimethicone, Avobenzone, Homosalate, Octinoxate, And Octisalate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Blistex Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 20 Nov, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part347 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Blistex Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2107300
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0041388008271
|
| UPC stands for Universal Product Code. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 10157-9904-1 | 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 | 20 Nov, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
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
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
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
Active ingredients purpose dimethicone 2.0% (w/w) lip protectant octinoxate 6.6% (w/w) sunscreen octisalate 4.4% (w/w) sunscreen
Product Elements:
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 blistex lip medex petrolatum, menthol, unspecified form, camphor (synthetic), and phenol petrolatum petrolatum menthol, unspecified form menthol, unspecified form camphor (synthetic) camphor (synthetic) phenol phenol lanolin microcrystalline wax cocoa butter yellow wax castor oil myristyl myristate diisopropyl adipate menthyl lactate, (-)- benzyl alcohol 3-((l-menthyl)oxy)propane-1,2-diol menthyl salicylate, (+/-)- saccharin eucalyptus oil clove oil blistex medicated lip dimethicone, camphor (synthetic), menthol, unspecified form, and phenol dimethicone dimethicone camphor (synthetic) camphor (synthetic) menthol, unspecified form menthol, unspecified form phenol phenol water mineral oil yellow wax petrolatum lanolin polyglyceryl-3 diisostearate paraffin alcohol ammonia glycerin allantoin peppermint oil hydrated silica palmitic acid cetyl alcohol stearyl alcohol calcium hydroxide lauric acid myristic acid sodium hydroxide oleic acid edetate calcium disodium anhydrous potassium hydroxide blistex five star lip protection broad spectrum dimethicone, avobenzone, homosalate, octinoxate, and octisalate dimethicone dimethicone avobenzone avobenzone homosalate homosalate octinoxate octinoxate octisalate octisalate microcrystalline wax octyldodecanol ceresin myristyl myristate stearyl behenate cetyl dimethicone 150 stearyl dimethicone (400 mpa.s at 50c) bis-diglyceryl polyacyladipate-2 candelilla wax .alpha.-tocopherol acetate tetrahexyldecyl ascorbate phenoxyethanol sunflower oil calendula officinalis flower wheat germ oil safflower oil sucralose sorbic acid citric acid monohydrate panthenol blistex complete moisture dimethicone, octinoxate, and octisalate dimethicone dimethicone octinoxate octinoxate octisalate octisalate ethylhexyl palmitate ethylhexyl stearate diethylhexyl adipate medium-chain triglycerides microcrystalline wax water glycerin hydrogenated soybean lecithin petrolatum ceresin 7-behenoylstearic acid hydrogenated jojoba oil, randomized sodium borate panthenol squalane cholesteryl/behenyl/octyldodecyl lauroyl glutamate phenoxyethanol saccharin sodium
Indications and Usage:
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
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
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
Uses temporarily protects and helps relieve chapped or cracked lips helps prevent sunburn
Warnings:
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.
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.
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.
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.
Do Not Use:
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.
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.
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.
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.
When Using:
When using this product do not get into eyes do not apply over large areas of the body or bandage
When using this product do not get into eyes do not apply over large areas of the body or bandage
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.
Dosage and Administration:
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
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
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
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
Stop Use:
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
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
Stop use and ask a doctor if rash occurs
Stop use and ask a doctor if rash occurs
Package Label Principal Display Panel:
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