Preparation H Soothing Relief Cooling
Witch Hazel
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0573-2889Preparation H Soothing Relief Cooling also known as Witch Hazel is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Preparation H Soothing Relief Cooling is 0573-2889. This drug is available in dosage form of Aerosol, Spray. The names of the active, medicinal ingredients in Preparation H Soothing Relief Cooling drug includes Witch Hazel - 200 mg/g . The currest status of Preparation H Soothing Relief Cooling drug is Active.
Drug Information:
| Drug NDC: | 0573-2889 |
| 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: | Preparation H Soothing Relief Cooling |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Preparation H |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Soothing Relief Cooling |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Witch Hazel |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol, Spray |
| 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: | WITCH HAZEL - 200 mg/g
|
| 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: | 12 Apr, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | part346 |
| 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: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2536738
|
| 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: | 101I4J0U34
|
| 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 |
|---|
| 0573-2889-01 | 77 g in 1 CANISTER (0573-2889-01) | 12 Apr, 2021 | 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 astringent
Product Elements:
Preparation h soothing relief cooling witch hazel witch hazel witch hazel aloe vera leaf anhydrous citric acid benzyl alcohol dehydroxanthan gum edetate disodium glycerin isobutane propylene glycol water sodium benzoate sodium citrate, unspecified form
Indications and Usage:
Uses ⢠helps relieve the local itching and discomfort associated with hemorrhoids ⢠temporary relief of irritation and burning ⢠aids in protecting irritated anorectal areas
Warnings:
Warnings for external use only when using this product ⢠do not exceed the recommended daily dosage unless directed by a doctor ⢠do not put this product into the rectum by using fingers or any mechanical device or applicator ⢠warning â avoid spraying in eyes. contents under pressure. do not puncture or incinerate. do not store at temperature above 120°f. ⢠warning â use only as directed. intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. stop use and ask a doctor if ⢠bleeding occurs ⢠condition worsens or does not improve within 7 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 ⢠do not exceed the recommended daily dosage unless directed by a doctor ⢠do not put this product into the rectum by using fingers or any mechanical device or applicator ⢠warning â avoid spraying in eyes. contents under pressure. do not puncture or incinerate. do not store at temperature above 120°f. ⢠warning â use only as directed. intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Dosage and Administration:
Directions ⢠adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. gently dry by patting or blotting with toilet tissue or a soft cloth before applying the spray. ⢠apply externally to the affected area up to 6 times daily or after each bowel movement ⢠children under 12 years of age: consult a doctor ⢠shake well before using ⢠hold 3 to 6â away from rectal area, spray to moisten and then wipe off excess, if desired
Stop Use:
Stop use and ask a doctor if ⢠bleeding occurs ⢠condition worsens or does not improve within 7 days
Package Label Principal Display Panel:
Principal display panel ndc 0573-2889-01 preparation h new! soothing relief cooling spray hemorrhoidal spray with aloe quickly soothes and cools discomfort relieves itching, burning and irritation gentle for daily use net wt 2.7 oz (77 g) prep h soothing relief cooling spray 2.7oz (77 g)
Further Questions:
Questions? call weekdays 9 am to 5 pm est at 1-800-99preph or 1-800-997-7374