NDC 60608-016 Bio-scriptives Lidum Hemorroidal (anorectal)

NDC Product Code 60608-016

NDC CODE: 60608-016

Proprietary Name: Bio-scriptives Lidum Hemorroidal (anorectal) 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.

NDC Code Structure

NDC 60608-016-01

Package Description: 1 TUBE in 1 BOX > 56 g in 1 TUBE (60608-016-00)

NDC 60608-016-03

Package Description: 15 TUBE in 1 BOX > 4.5 g in 1 TUBE (60608-016-02)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Bio-scriptives Lidum Hemorroidal (anorectal) with NDC 60608-016 is a product labeled by Bio-scriptives, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1366789 and 1436083.

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)
  • WATER (UNII: 059QF0KO0R)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
  • ETHYL OLEATE (UNII: Z2Z439864Y)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TOCOPHERSOLAN (UNII: O03S90U1F2)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • ALLANTOIN (UNII: 344S277G0Z)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • METHYL NICOTINATE (UNII: 7B1AVU9DJN)

Product Labeler Information

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

Labeler Name: Bio-scriptives, Inc.
Labeler Code: 60608
Start Marketing Date: 03-04-2012 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Bio-scriptives Lidum Hemorroidal (anorectal) 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

Lidocaine 5%

Purpose

Local Anesthetic

Uses

■ For the temporary relief of local discomfort associated with anorectal disorders■ For the temporary relief of pain, soreness, and burning.

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.

Stop Use And Consult A Doctor If:

■ condition worsens or does not improve within 7 days ■ bleeding occurs ■ allergic reaction occurs ■ redness, irritation,
swelling, pain or other symptoms develop or increase

Directions

■ Children under 12 years of age: consult a doctor. ■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally to the affected area up to 6 times daily.

Inactive Ingredients

Aloe, Water, Cholesterol, Isopropyl Mysristate, Aqua, Caprylic/Capric Triglyceride, Propylene Glycol, Hydrogenated Phosphatidylcholine, Glyceryl Stearate, PEG-100 Stearate, Arginine HCI, Ethyl Oleate, Propylene Glycol, Tocophersolan, Cetyl Alcohol, Triethanolamine, Xanthan Gum, Tocopherol, Allantoin, Aloe Barbadensis Leaf, Methylisothiazolinone, Methyl Nicotinate

Package And Lidum Images

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