NDC 0573-0554 Preparation H Rapid Relief

Glycerin, Lidocaine, Phenylephrine Hydrochloride

NDC Product Code 0573-0554

NDC Code: 0573-0554

Proprietary Name: Preparation H Rapid Relief Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Glycerin, Lidocaine, Phenylephrine Hydrochloride Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 0573 - Wyeth Consumer Healthcare Llc
    • 0573-0554 - Preparation H Rapid Relief

NDC 0573-0554-10

Package Description: 10 POUCH in 1 CARTON > 1 CLOTH in 1 POUCH

NDC 0573-0554-20

Package Description: 20 POUCH in 1 CARTON > 1 CLOTH in 1 POUCH

NDC 0573-0554-30

Package Description: 30 POUCH in 1 CARTON > 1 CLOTH in 1 POUCH

NDC Product Information

Preparation H Rapid Relief with NDC 0573-0554 is a a human over the counter drug product labeled by Wyeth Consumer Healthcare Llc. The generic name of Preparation H Rapid Relief is glycerin, lidocaine, phenylephrine hydrochloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Wyeth Consumer Healthcare Llc

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Preparation H Rapid Relief Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GLYCERIN 200 mg/1
  • LIDOCAINE 50 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wyeth Consumer Healthcare Llc
Labeler Code: 0573
FDA Application Number: part346 Additional informationCallout TooltipWhat is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 03-01-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Preparation H Rapid Relief Product Label Images

Preparation H Rapid Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposesGlycerin 20%ProtectantLidocaine 5%Local anestheticPhenylephrine HCl 0.25%Vasoconstrictor

Indications & Usage

  • Usesfor temporary relief of pain, soreness and burninghelps relieve the local itching and discomfort associated with hemorrhoidstemporarily reduces the swelling associated with irritated hemorrhoidal tissuetemporarily provides a coating for relief of anorectal discomfortstemporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

WarningsFor external use only

Ask A Doctor Before Use If You Have

  • Heart diseasehigh blood pressurethyroid diseasediabetesdifficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

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

  • Wash hands after use. Avoid contact with eyesdo not exceed the recommended daily dosage unless directed by a doctordo not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • Bleeding occurscondition worsens or does not improve within 7 daysan allergic reaction developsthe symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsadults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with a tissue or soft cloth before applying wipe.apply externally to affected area up to 4 times daily.unfold wipe and gently apply to the affected area by patting and then discard.children under 12 years of age: ask a doctor

Storage And Handling

  • Other informationstore at 20-25°C (68-77°F)for best results, flush only one at a time

Inactive Ingredient

Inactive ingredientsaloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, edetate disodium, propylene glycol, purified water, sodium benzoate

Otc - Questions

Questions or comments?Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

* Please review the disclaimer below.

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