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
Blistex Inc
Human Otc Drug
NDC 10157-9910Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) also known as Dimethicone, Octinoxate, Octisalate, Camphor (synthetic), Menthol, Unspecified Form, And Phenol is a human otc drug labeled by 'Blistex Inc'. National Drug Code (NDC) number for Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) is 10157-9910. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) drug includes . The currest status of Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) drug is Active.
Drug Information:
| Drug NDC: | 10157-9910 |
| 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 Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) |
| 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: | Dimethicone, Octinoxate, Octisalate, Camphor (synthetic), Menthol, Unspecified Form, And Phenol |
| 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: | 03 Feb, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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: | 0041388003153
|
| 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 |
|---|
| 10157-9910-1 | 1 KIT in 1 CARTON (10157-9910-1) * 4.25 g in 1 CYLINDER * 6 g in 1 TUBE * 4.25 g in 1 CYLINDER | 03 Feb, 2020 | 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 dimethicone 2.0% (w/w) lip protectant octinoxate 6.6% (w/w) sunscreen octisalate 4.4% (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
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
Product Elements:
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 blistex medicated berry lip balm dimethicone, octinoxate, and octisalate dimethicone dimethicone octinoxate octinoxate octisalate octisalate mineral oil petrolatum ceresin candelilla wax lanolin oil yellow wax isopropyl myristate lanolin polybutene (1400 mw) cetyl palmitate cetyl alcohol paraffin cocoa butter menthol, unspecified form phenoxyethanol .alpha.,.alpha.-dibromo-d-camphor titanium dioxide d&c red no. 6 blistex medicated lip balm dimethicone, octinoxate, and octisalate dimethicone dimethicone octinoxate octinoxate octisalate octisalate mineral oil petrolatum ceresin candelilla wax lanolin oil yellow wax isopropyl myristate lanolin polybutene (1400 mw) cetyl palmitate cetyl alcohol paraffin cocoa butter menthol, unspecified form phenoxyethanol .alpha.,.alpha.-dibromo-d-camphor methyl salicylate titanium dioxide d&c red no. 6 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
Indications and Usage:
Uses temporarily protects and helps relieve chapped or cracked lips helps prevent sunburn
Uses temporarily protects and helps relieve chapped or cracked lips helps prevent sunburn
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:
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.
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.
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.
Do Not Use:
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.
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.
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.
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.
When using this product do not get into eyes do not apply over large areas of the body or bandage
Dosage and Administration:
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
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
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
Stop Use:
Stop use and ask a doctor if rash occurs
Stop use and ask a doctor if rash occurs
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
Package Label Principal Display Panel:
Principal display panel - kit carton blistex ® medicated variety pack helps heal, soothe & protect there's no bliss like blistex ® principal display panel - kit carton