NDC 67234-024 Natureplex Hemorrhoidal

Witch Hazel And Phenylephrine Hydrochloride

NDC Product Code 67234-024

NDC 67234-024-01

Package Description: 1 TUBE in 1 BOX > 25 g in 1 TUBE

NDC Product Information

Natureplex Hemorrhoidal with NDC 67234-024 is a a human over the counter drug product labeled by Natureplex Llc. The generic name of Natureplex Hemorrhoidal is witch hazel and phenylephrine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Natureplex Llc

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.

Natureplex Hemorrhoidal 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 mg/g
  • PHENYLEPHRINE HYDROCHLORIDE .0025 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.

  • ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZOPHENONE (UNII: 701M4TTV9O)
  • HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)

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: Natureplex Llc
Labeler Code: 67234
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: 03-18-2014 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: 12-31-2021 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.

Natureplex Hemorrhoidal Product Label Images

Natureplex Hemorrhoidal 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 ingredientsPurposesPhenylephrine HCl 0.25%Hemorrhoidal (anorectal) GelHamamelis Virginiana (witch hazel) 50%Hemorrhoidal (anorectal) Gel

Uses

  • Temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorderstemporarily reduces the swelling associated with irriation in hemorrhoids and other anorectal disorderstemporarily shrinks hemorrhoidal tissueaids in protecting irritated anorectal areastemporary relief of burning

Warnings

For external use only.

Ask A Doctor Before Use If You Have

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are 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

Stop Use And Ask A Doctor If

  • Bleeding occursthe condition worsens or does not improve within 7 days. These may be signs of a serious condition.

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: 800-222-1222.

Directions

  • Adults:when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel.apply externally to affected area up to 4 times daily or after each bowel movementChildren under 12 years: ask a doctor

Other Information

  • Store at 15 to 30°C (59 to 86°F)close cap tightly after useTamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

Aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

* Please review the disclaimer below.