NDC 70000-0468 Hemorrhoidal Relief Cream

Lidocaine

NDC Product Code 70000-0468

NDC 70000-0468-1

Package Description: 1 TUBE in 1 BOX > 30 g in 1 TUBE

NDC Product Information

Hemorrhoidal Relief Cream with NDC 70000-0468 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Hemorrhoidal Relief Cream is lidocaine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cardinal Health

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.

Hemorrhoidal Relief Cream 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.

  • LIDOCAINE 50 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)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GRAPE (UNII: 6X543N684K)

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: Cardinal Health
Labeler Code: 70000
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: 08-15-2019 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’.

* Please review the disclaimer below.

Hemorrhoidal Relief Cream Product Label Images

Hemorrhoidal Relief Cream 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

Indications & Usage

UsesTemporarily relieves pain, itching and discomfort due to anorectal disorders.

Warnings

For External Use OnlyAllergy Alert- Certain persons can develop allergic reactions to ingredients in this product.

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart 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.

Otc - When Using

  • When using this productavoid contact with eyesdo not put this product into the rectum by using fingers or any mechanical device or applicatordo not exceed the recommended daily dosage unless directed by a doctor

Otc - Stop Use

  • Stop use and ask a doctor if retal bleeding occurs condition worsens or does not improve within 7 daysallergic reaction occurssymptoms clear up and return within a few daysredness, irritation, swelling, pain, or other symptoms begin 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 (1-800-222-1222) right away.

Dosage & Administration

  • DirectionsAdults: when practical, cleanse the affected area with mild soap and warm water. Rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.Children under 12 years of age: consult a doctor.

Inactive Ingredient

Inactive ingredients: Aloe Barbadensis Leaf Juice Extract, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, vitamin E Acetate, Vitis Vinifera (Grape) Skin Extract

Other Safety Information

  • Store at 20-25
  • 0C (68-77
  • OF)
  • To secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.

Otc - Questions

Questions & Comments? 516-444-5749

Otc - Purpose

Local Anesthetic

* Please review the disclaimer below.