Head And Shoulders Refreshing Relief
Head And Shoulders
Ultra Distribuciones Internacionales, S.a. De C.v.
Human Otc Drug
NDC 72389-108Head And Shoulders Refreshing Relief also known as Head And Shoulders is a human otc drug labeled by 'Ultra Distribuciones Internacionales, S.a. De C.v.'. National Drug Code (NDC) number for Head And Shoulders Refreshing Relief is 72389-108. This drug is available in dosage form of Lotion/shampoo. The names of the active, medicinal ingredients in Head And Shoulders Refreshing Relief drug includes Pyrithione Zinc - 1 g/100mL . The currest status of Head And Shoulders Refreshing Relief drug is Active.
Drug Information:
| Drug NDC: | 72389-108 |
| 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: | Head And Shoulders Refreshing Relief |
| 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: | Head And Shoulders |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ultra Distribuciones Internacionales, S.a. De C.v. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion/shampoo |
| 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: | PYRITHIONE ZINC - 1 g/100mL
|
| 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: | 27 Sep, 2018 |
| 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: | part358H |
| 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: | ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 209884
1043244
|
| 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. |
| UNII: | R953O2RHZ5
|
| 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 |
|---|
| 72389-108-02 | 375 mL in 1 BOTTLE, PLASTIC (72389-108-02) | 27 Sep, 2018 | N/A | No |
| 72389-108-03 | 180 mL in 1 BOTTLE, PLASTIC (72389-108-03) | 27 Sep, 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:
Purpose with refreshing ingredients for immediate sensation *up to 100% dandruff free with regular use, h&s 3action formula cleans, protects and hydrates hair and scalf. head and shoulders refreshing relief with balanced ph contains ingredients that in contact with the skin unleash refreshing sensations that immediate reduce the itching related to dandruff *visible dandruff, using it often.
Product Elements:
Head and shoulders refreshing relief head and shoulders coco monoethanolamide mentha piperita hydroxycitronellal fd&c yellow no. 5 fd&c blue no. 1 menthol, unspecified form sodium lauryl sulfate sodium laureth sulfate glycol distearate pyrithione zinc pyrithione zinc linalool, (-)- magnesium carbonate hydroxide dimethicone .alpha.-hexylcinnamaldehyde sodium chloride sodium xylenesulfonate methylisothiazolinone sodium benzoate guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) hydrochloric acid zinc carbonate zinc cation cetyl alcohol benzyl alcohol magnesium sulfate, unspecified mentha arvensis leaf oil water
Indications and Usage:
Indications: helps prevent recurrence of flaking and itching associated with dandruff
Warnings:
Warnings for external use only.
When Using:
When using this product -do not get into eyes. if contact occurs, rinse thoroughly with water
Dosage and Administration:
Directions -shake well before use - apply in wet hair - massage into scalp - rinse -repeat as desired -for best results use at least twice a week or as directed by a doctor -for maximum dandruff control, use every time you shampoo
Stop Use:
Stop use and ask doctor if condition worsens or does not improve after regular use as directed
Package Label Principal Display Panel:
Head & shoulders antidandruff shampoo refreshing relief refreshing relief refreshing relief
Further Questions:
Distributed by: ultra distribuciones internacionales, s.a. de c.v. made in mexico