NDC 63868-483 Hemorroidal Cooling Gel

Phenylephrine, Witch Hazel

NDC Product Code 63868-483

NDC Code: 63868-483

Proprietary Name: Hemorroidal Cooling Gel What 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: Phenylephrine, Witch Hazel What 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.

NDC Code Structure

  • 63868 - Chain Drug Marketing Association
    • 63868-483 - Hemorroidal Cooling Gel

NDC 63868-483-18

Package Description: 1 TUBE in 1 BOX > 51 g in 1 TUBE

NDC Product Information

Hemorroidal Cooling Gel with NDC 63868-483 is a a human over the counter drug product labeled by Chain Drug Marketing Association. The generic name of Hemorroidal Cooling Gel is phenylephrine, witch hazel. The product's dosage form is gel and is administered via topical form.

Labeler Name: Chain Drug Marketing Association

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Hemorroidal Cooling Gel 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 .5 g/100g
  • PHENYLEPHRINE HYDROCHLORIDE .25 g/100g

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.

  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • SULISOBENZONE (UNII: 1W6L629B4K)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)

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: Chain Drug Marketing Association
Labeler Code: 63868
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: 07-15-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

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Hemorroidal Cooling Gel 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 Ingredient

Phenylephrine HCI 0.25%

Witch Hazel 50%

Purpose

Vasoconstrictor

Astringent

Uses

  • Helps relieve the local itching and discomfort associated with hemorrhoidstemporarily relief of irritation and burningtemporarily shrinks hemorrhoidal tissueaids in protecting irritated anorectal areas

Stop Use And Ask A Doctor

  • Bleeding occurscondition worsens or does not improve within 7 days

If Pregnant Or Breast Feeding

Ask a doctor before use

Keep Out Of The Reach Of Children

If swallowed get medical help or contact Poison Control Center right away

Directions

  • Children under 12 years of age; ask a doctor before useAdults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipegently dry by patting or blotting with a tissue or soft cloth before applyingwhen first opening tube, remove foil sealapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Warnings

  • For External Use OnlyAsk doctor before use if you haveheart diseasehigh blood pressurethyroid diseasediabetesdifficulty urinating due to an enlarged prostate glandAsk doctor 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 doctordo not put into the rectum by using fingers or any mechanical device or applicator

Other Information

Store at room temperature 20°-25°C (68°-77°F)** This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®.

Inactive Ingredients

Aloe barbadensis gel, benzophenone-4, Acetate disodium, Hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, Vitamin E, water

Distributed By

C.D.M.A. Inc. ©43157 W 9 Mile Rd.Novi, MI. 48375 USA1-800-935-2362www.qualitychoice.comProduct of PRC

* Please review the disclaimer below.

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