NDC 71416-001 Protocoxil

NDC Product Information

Protocoxil with NDC 71416-001 is product labeled by Bio�ekuiliber�llc. The product's dosage form is and is administered via form.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • WATER (UNII: 059QF0KO0R)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MARITIME PINE (UNII: 50JZ5Z98QY)
  • WHITE PEPPER OIL (UNII: 2AM83DL9FV)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)

Product Labeler Information

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

Labeler Name: Bio�ekuiliber�llc
Labeler Code: 71416
Start Marketing Date: 05-09-2017 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: 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.

Protocoxil Product Label Images

Protocoxil 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 Ingredients

Benzyl alcohol 10%

Purpose

External analgesic

Use

  • For the temporary relief of pain and itching associated with minor skin irritations

Warnings

For external use only

Do Not Use

  • In the eyes

Stop Use And Ask A Doctor If

  • Condition worsensif symptoms persist for more than 7 daysif symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: consult a physician

Other Information

  • Protect this product from excessive heat and direct sun

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, aqua (deionized water), disodium EDTA, glycerin, isopropyl alcohol, pinus pinaster bark extract, piper nigrum (pepper) seed oil, tocopheryl acetate, triethanolamine

* Please review the disclaimer below.