Preparation H
Mineral Oil, Petrolatum, Phenylephrine Hcl
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0573-2871Preparation H also known as Mineral Oil, Petrolatum, Phenylephrine Hcl is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Preparation H is 0573-2871. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Preparation H drug includes Mineral Oil - 140 mg/g Petrolatum - 749 mg/g Phenylephrine Hydrochloride - 2.5 mg/g . The currest status of Preparation H drug is Active.
Drug Information:
| Drug NDC: | 0573-2871 |
| 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 |
| 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: | Mineral Oil, Petrolatum, Phenylephrine Hcl |
| 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: | Ointment |
| 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: | MINERAL OIL - 140 mg/g
PETROLATUM - 749 mg/g
PHENYLEPHRINE HYDROCHLORIDE - 2.5 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: | 01 Mar, 2004 |
| 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: | 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: | 1372298
|
| 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: | T5L8T28FGP
4T6H12BN9U
04JA59TNSJ
|
| 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. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0573-2871-04 | 2 CARTON in 1 PACKAGE (0573-2871-04) / 1 TUBE in 1 CARTON / 57 g in 1 TUBE | 01 Mar, 2004 | N/A | No |
| 0573-2871-10 | 1 TUBE in 1 CARTON (0573-2871-10) / 28 g in 1 TUBE | 01 Mar, 2004 | N/A | No |
| 0573-2871-20 | 1 TUBE in 1 CARTON (0573-2871-20) / 57 g in 1 TUBE | 01 Mar, 2004 | N/A | No |
| 0573-2871-91 | 1 TUBE in 1 CARTON (0573-2871-91) / 28 g in 1 TUBE | 01 Mar, 2018 | N/A | No |
| 0573-2871-92 | 1 TUBE in 1 CARTON (0573-2871-92) / 57 g in 1 TUBE | 01 Mar, 2018 | N/A | No |
| 0573-2871-93 | 1 TUBE in 1 CARTON (0573-2871-93) / 28 g in 1 TUBE | 01 Jun, 2019 | N/A | No |
| 0573-2871-94 | 1 TUBE in 1 CARTON (0573-2871-94) / 57 g in 1 TUBE | 17 May, 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:
Purposes protectant protectant vasoconstrictor
Product Elements:
Preparation h mineral oil, petrolatum, phenylephrine hcl phenylephrine hydrochloride phenylephrine mineral oil mineral oil petrolatum petrolatum benzoic acid butylated hydroxyanisole corn oil glycerin lanolin lanolin alcohols methylparaben paraffin propylparaben water thyme white wax tocopherol smooth yellow ointment
Indications and Usage:
Uses ⢠helps relieve the local itching and discomfort associated with hemorrhoids ⢠temporarily shrinks hemorrhoidal tissue and relieves burning ⢠temporarily provides a coating for relief of anorectal discomforts ⢠temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Warnings:
Warnings for external and/or intrarectal use only ask a doctor before use if you have ⢠heart disease ⢠high blood pressure ⢠thyroid disease ⢠diabetes ⢠difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. when using this product do not exceed the recommended daily dosage unless directed by a doctor. stop use and ask a doctor if ⢠bleeding occurs ⢠condition worsens or does not improve within 7 days ⢠introduction of applicator into the rectum causes additional pain if pregnant or breast-feeding, ask a health professional before use. 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.
Dosage and Administration:
Directions ⢠adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. gently dry by patting or blotting with a tissue or a soft cloth before applying ointment. ⢠when first opening the tube, puncture foil seal with top end of cap ⢠apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement ⢠intrarectal use: ⢠remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum ⢠thoroughly cleanse applicator after each use and replace cover ⢠also apply ointment to external area ⢠regular use provides continual therapy for relief of symptoms ⢠children under 12 years of age: ask a doctor
Stop Use:
Stop use and ask a doctor if ⢠bleeding occurs ⢠condition worsens or does not improve within 7 days ⢠introduction of applicator into the rectum causes additional pain
Package Label Principal Display Panel:
Principal display panel - 28 g tube label this package contains an outer carton. do not buy if outer carton is missing. preparation h ® hemorrhoidal ointment prevents further irritation ⢠prompt, soothing relief from painful burning, itching and discomfort ⢠shrinks swollen hemorrhoidal tissue ⢠protects irritated tissue ⢠relieves internal and external discomfort net wt 1 oz (28 g) principal display panel - 28 g tube label
Principal display panel - 28 g tube carton preparation h ® hemorrhoidal ointment prevents further irritation ⢠prompt, soothing relief from painful burning, itching and discomfort ⢠shrinks swollen hemorrhoidal tissue ⢠protects irritated tissue ⢠relieves internal and external discomfort net wt 1 oz (28 g) principal display panel - 28 g tube carton
Principal display panel - 28 g tube label - paa119867 preparation h ® hemorrhoidal ointment prevents further irritation ⢠prompt, soothing relief from painful burning, itching, & discomfort ⢠shrinks swollen hemorrhoidal tissue ⢠protects irritated tissue ⢠relieves internal & external discomfort net wt 1.0 oz (28 g) principal display panel - 28 g tube label - paa119867
Principal display panel - 28 g tube carton - paa119868 preparation h ® hemorrhoidal ointment prevents further irritation new look, same size! ⢠prompt, soothing relief from painful burning, itching, & discomfort ⢠shrinks swollen hemorrhoidal tissue ⢠protects irritated tissue ⢠relieves internal & external discomfort 1 tube | net wt 1 oz (28 g) principal display panel - 28 g tube carton - paa119868
Principal display panel - 57 g tube label preparation h ® hemorrhoidal ointment prevents further irritation ⢠prompt, soothing relief from painful burning, itching, & discomfort ⢠shrinks swollen hemorrhoidal tissue ⢠protects irritated tissue ⢠relieves internal & external discomfort net wt 2.0 oz (57 g) principal display panel - 57 g tube label
Principal display panel - 57 g tube carton preparation h ® hemorrhoidal ointment prevents further irritation ⢠prompt, soothing relief from painful burning, itching, & discomfort ⢠shrinks swollen hemorrhoidal tissue ⢠protects irritated tissue ⢠relieves internal & external discomfort 1 tube | net wt 2 oz (57 g) principal display panel - 57 g tube carton
Further Questions:
Questions or comments? call weekdays 9 am to 5 pm est at 1-800-99preph or 1-800-997-7374.