NDC 37808-993 Heb Hemorrhoidal Cooling Gel

Witch Hazel And Phenylephrine Hydrochloride

NDC Product Code 37808-993

NDC 37808-993-24

Package Description: 1 TUBE in 1 CARTON > 26 g in 1 TUBE

NDC Product Information

Heb Hemorrhoidal Cooling Gel with NDC 37808-993 is a a human over the counter drug product labeled by Heb. The generic name of Heb Hemorrhoidal Cooling Gel is witch hazel and phenylephrine hydrochloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: Heb

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Heb Hemorrhoidal 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 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SULISOBENZONE (UNII: 1W6L629B4K)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • 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: Heb
Labeler Code: 37808
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: 10-18-2018 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 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’.

* Please review the disclaimer below.

Heb Hemorrhoidal Cooling Gel Product Label Images

Heb Hemorrhoidal 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

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposeHamamelis virginiana (witch hazel) 50%AstringentPhenylephrine hydrochloride 0.25%Vasoconstrictor

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.

Do Not Use This Product

  • If you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask A Doctor Or Pharmacist Before Use If You Are

  • Presently taking a prescription drug for high blood pressure of depression.

When Using This Product

  • Do not exceed recommended daily dosage unless directed by a doctordo not put into rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • Condition worsens or does not improve within 7 daysbleeding occurs

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

  • Adultswhen 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 gelapply externally to affected area up to 4 times daily or after each bowel movementChildren under 12 years old: Ask a doctor

Other Information

  • Store at 15 to 30°C (59 to 86°F)Tamper 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.