NDC 11701-083 Critic-aid Clear

Petrolatum

NDC Product Code 11701-083

NDC Code: 11701-083

Proprietary Name: Critic-aid Clear Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Petrolatum Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 11701 - Coloplast Corp.
    • 11701-083 - Critic-aid Clear

NDC 11701-083-22

Package Description: 4 g in 1 PACKET

NDC 11701-083-32

Package Description: 170 g in 1 TUBE

NDC 11701-083-33

Package Description: 71 g in 1 TUBE

NDC Product Information

Critic-aid Clear with NDC 11701-083 is a a human over the counter drug product labeled by Coloplast Corp.. The generic name of Critic-aid Clear is petrolatum. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Coloplast Corp.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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 Additional informationCallout TooltipWhat 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.


Critic-aid Clear Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PETROLATUM 865 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • DIMETHICONE 1000 (UNII: MCU2324216)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Coloplast Corp.
Labeler Code: 11701
FDA Application Number: part347 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-22-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Critic-aid Clear Product Label Images

Critic-aid Clear 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

Manufactured by: Coloplast Corp., 1940 Commerce Drive,North Mankato, MN 56003Distributed by: Coloplast Corp. 1601 West River Road,Minneapolis, MN 55411, U.S.A.

Active Ingredient

Petrolatum, 86.5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin. Helps seal out wetness.

Warnings

For external use only.

Otc - When Using

  • When using this productDo not get into eyes.

Otc - Do Not Use

  • Do not use on:deep or puncture woundsanimal bitesserious burns.

Otc - Ask Doctor

  • Stop use and ask a doctor ifcondition worsenssymptoms last more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the affected area and dry thoroughly.Knead before use.Apply a thin layer liberally enough to cover yet visualize the skin.Apply to the affected area twice daily (morning and night), or as directed by a doctor.Supervise children in the use of this product.

Inactive Ingredients

Cellulose gum (CMC), dimethicone, tocopheryl acetate, zinc oxide

* Please review the disclaimer below.

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