Herstat
Moisturizing Lip Care Stick
Herstat (usa) Inc.
Human Otc Drug
NDC 90100-202Herstat also known as Moisturizing Lip Care Stick is a human otc drug labeled by 'Herstat (usa) Inc.'. National Drug Code (NDC) number for Herstat is 90100-202. This drug is available in dosage form of Lipstick. The names of the active, medicinal ingredients in Herstat drug includes Petrolatum - 47.95 g/100g . The currest status of Herstat drug is Active.
Drug Information:
| Drug NDC: | 90100-202 |
| 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: | Herstat |
| 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: | Moisturizing Lip Care Stick |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Herstat (usa) Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lipstick |
| 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: | PETROLATUM - 47.95 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 30 Nov, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 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, 2024 |
| 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: | Herstat (USA) Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0658556030585
|
| UPC stands for Universal Product Code. |
| UNII: | 4T6H12BN9U
|
| 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 |
|---|
| 90100-202-04 | 1 TUBE in 1 CARTON (90100-202-04) / 4 g in 1 TUBE | 30 Nov, 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:
Purpose lip protectant
Product Elements:
Herstat moisturizing lip care stick microcrystalline wax mineral oil c10-30 cholesterol/lanosterol esters carnauba wax propylene glycol propolis wax petrolatum petrolatum
Indications and Usage:
Uses ⢠relieves dryness. ⢠helps prevent, protect, and relieve chapped lips
Warnings:
Warnings for external use only. when using this product: ⢠do not get into eyes. ⢠test on a small area of your forearm before use. ⢠propolis may cause skin irritation. ⢠discontinue use if rash appears. ⢠this product should not be used in or around the eyes. ⢠do not use if allergic to bee stings or bee by-products. 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. ⢠as with any product, ask a doctor before use if pregnant or breast-feeding. 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. ⢠test on a small area of your forearm before use. ⢠propolis may cause skin irritation. ⢠discontinue use if rash appears. ⢠this product should not be used in or around the eyes. ⢠do not use if allergic to bee stings or bee by-products. 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. ⢠as with any product, ask a doctor before use if pregnant or breast-feeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions apply as often as required to relieve dry lips and to help prevent, protect and relieve chapped lips. do not use directly on a cold sore during an outbreak.
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. ⢠as with any product, ask a doctor before use if pregnant or breast-feeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Herstat - moisturizing lip care stick - outer label herstat® moisturizing lip care stick care for your lips between cold sore outbreaks lip care stick | lip protectant 0.14 oz (4g) net weight ndc 90100 202 04 fragrance free moisturizing protectant cruelty free using herstat: for best results, apply herstat lip care as often as required in between cold sore outbreaks. propolis contains 3% purified propolis extract to help soothe and moisturize dry lips. manufactured in the usa for lisoma international ltd, 1-3 south street, chichester, po19 1eh, uk. distributed by herstat (usa) inc. 380 s cache street, suite 100 â 10219, jackson, wyoming, 83001, usa. herstat® and dr sosnowskiâs® are registered trademark of lisoma international ltd. lip protectant recommended for use between cold sore outbreaks [drug facts] herstat® lot xxxxx xx/xx secondary packaging
Herstat - moisturizing lip care stick - inner label herstat® moisturizing lip care stick lip protectant 0.17 oz (4g) net weight with 3% propolis active ingredient white petrolatum 47.95%........................purpose / lip protectant do not use if allergic to bee stings or bee by-products. keep out of reach of children. directions apply as needed. manufactured for lisoma international ltd, 1-3 south street, chichester, uk. call (1) 307 201 5478 or go to www.herstat.com lot xxxxx xx/xx image description
Further Questions:
Questions? call (1) 307 201 5478 or go to www.herstat.com