NDC 0573-2889 Preparation H Soothing Relief Cooling

Witch Hazel

NDC Product Code 0573-2889

NDC 0573-2889-01

Package Description: 77 g in 1 CANISTER

NDC Product Information

Preparation H Soothing Relief Cooling with NDC 0573-2889 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Preparation H Soothing Relief Cooling is witch hazel. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

Product Type: Human Otc Drug What 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 Soothing Relief Cooling Active Ingredient(s)

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

  • WITCH HAZEL 200 mg/g

Inactive Ingredient(s)

About 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)
  • DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOBUTANE (UNII: BXR49TP611)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Administration Route(s)

What 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

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0573
FDA Application Number: part346 What 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. What 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: 04-12-2021 What 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: 12-31-2022 What 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 - NO What 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Preparation H Soothing Relief Cooling Product Label Images

Preparation H Soothing Relief Cooling 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

Active Ingredients

Witch hazel 20%

Purpose

Astringent

Uses

  • ▪helps relieve the local itching and discomfort associated with hemorrhoids▪temporary relief of irritation and burning▪aids in protecting irritated anorectal areas

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 – avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.▪Warning – 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.

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 6” away from rectal area, spray to moisten and then wipe off excess, if desired

Other Information

  • ▪store at 20-25°C (68-77°F)

Inactive Ingredients

Aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, dehydroxanthan gum, edetate disodium, glycerin, isobutane, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

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

Additional Information

No Touch SprayDo not use if sleeve band around cap is broken or missingDist. By: GSK Consumer HealthcareWarren, NJ 07059Trademarks owned or licensed by GSK©2021 GSK or licensorPAA172637 (Front Carton)

* Please review the disclaimer below.