Fak Care4 Bus And School Yellow Orm D
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Benzalkonium Chloride, Lidocaine Hydrochloride, Isopropyl Alcohol, Benzocaine, Alcohol
Gfa Production (xiamen) Co., Ltd.
Human Otc Drug
NDC 50814-030Fak Care4 Bus And School Yellow Orm D also known as Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Benzalkonium Chloride, Lidocaine Hydrochloride, Isopropyl Alcohol, Benzocaine, Alcohol is a human otc drug labeled by 'Gfa Production (xiamen) Co., Ltd.'. National Drug Code (NDC) number for Fak Care4 Bus And School Yellow Orm D is 50814-030. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Fak Care4 Bus And School Yellow Orm D drug includes . The currest status of Fak Care4 Bus And School Yellow Orm D drug is Active.
Drug Information:
| Drug NDC: | 50814-030 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Fak Care4 Bus And School Yellow Orm D |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Benzalkonium Chloride, Lidocaine Hydrochloride, Isopropyl Alcohol, Benzocaine, Alcohol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Gfa Production (xiamen) Co., Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 08 Feb, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333B |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GFA Production (Xiamen) Co., Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 204602
797544
1012100
1038558
1046313
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50814-030-01 | 1 KIT in 1 KIT (50814-030-01) * 2 BOX in 1 KIT / 1 BAG in 1 BOX (50814-001-01) / .45 g in 1 BAG * 2 BOX in 1 KIT / 1 POUCH in 1 BOX (50814-002-01) / .45 g in 1 POUCH * 2 PACKAGE in 1 KIT / .5 mL in 1 PACKAGE (52124-0008-1) * 2 PACKAGE in 1 KIT / .9 g in 1 PACKAGE (50814-009-01) * 2 BAG in 1 KIT / .9 g in 1 BAG (50814-007-01) | 08 Feb, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose first aid antibiotic
Purpose first aid antiseptic pain relieving cream
Purpose antiseptic
Purpose: first aid antiseptic
Purpose topical anesthetic antiseptic
Product Elements:
Fak care4 bus and school yellow orm d bacitracin zinc, neomycin sulfate, polymyxin b sulfate, benzalkonium chloride, lidocaine hydrochloride, isopropyl alcohol, benzocaine, alcohol first aid antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate mineral oil petrolatum water bacitracin zinc bacitracin neomycin sulfate neomycin polymyxin b sulfate polymyxin b first aid antiseptic pain relieving benzalkonium chloride, lidocaine hydrochloride glycerin water benzalkonium chloride benzalkonium lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol cleansing isopropyl alcohol water isopropyl alcohol isopropyl alcohol antiseptic towelette benzalkonium chloride water benzalkonium chloride benzalkonium insect sting relief pad benzocaine,alcohol water benzocaine benzocaine alcohol alcohol
Indications and Usage:
Use first aid to help prevent infection in minor cuts, scrapes, and burns.
Uses first aid to help prevent infection in minor cuts, scrapes, and burns. for the temporary relief of pain and itching associated with minor burns, minor cuts, and scrapes.
Use: for preparation of the skin before injection.
Use: for professional and hospital use. helps prevent infection. antiseptic cleansing of face, hands and body without soap and water.
Use: for the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.
Warnings:
Warnings for external use only. do not use ⢠do not use ⢠in the eyes ⢠over large areas of the body ⢠if you are allergic to any of the ingredients ⢠longer than 1 week unless directed by a doctor. ask a doctor before use if you have ⢠deep or puncture wounds ⢠animal bites ⢠serious burns. stop use and ask a doctor if ⢠the condition persists or gets worse ⢠a rash or other allergic reaction develops. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. do not use ⢠in the eyes ⢠over large areas of the body ⢠in large quantities ⢠over raw surfaces or blistered areas ⢠longer than 1 week unless directed by a doctor ask a doctor before use if you have ⢠deep or puncture wounds ⢠animal bites ⢠serious burns. stop use and ask a doctor if ⢠the condition persists or gets worse ⢠symptoms persist for more than 7 days or clear up and occur again within a few days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings: for external use only. flammable: keep away from fire or flame. do not use: with electrocautery, in the eyes stop use if irritation and redness develop. if condition persists for more than 72 hours, consult your doctor. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings: for external use only. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. if unusual redness, swelling or other symptoms occur, consult a physician immediately. do not use: in the eyes, or over large areas of the body.
Warnings: for external use only. do not use: in eyes, on broken skin, deep puncture wounds. if unusual redness,swelling, irritation or other symptoms occur, consult a physician immediately. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. flammable - keep away from fire or flame. avoid contact with eyes. if this happens, rinse thoroughly with water.
Do Not Use:
Warnings for external use only. do not use ⢠do not use ⢠in the eyes ⢠over large areas of the body ⢠if you are allergic to any of the ingredients ⢠longer than 1 week unless directed by a doctor. ask a doctor before use if you have ⢠deep or puncture wounds ⢠animal bites ⢠serious burns. stop use and ask a doctor if ⢠the condition persists or gets worse ⢠a rash or other allergic reaction develops. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. do not use ⢠in the eyes ⢠over large areas of the body ⢠in large quantities ⢠over raw surfaces or blistered areas ⢠longer than 1 week unless directed by a doctor ask a doctor before use if you have ⢠deep or puncture wounds ⢠animal bites ⢠serious burns. stop use and ask a doctor if ⢠the condition persists or gets worse ⢠symptoms persist for more than 7 days or clear up and occur again within a few days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings: for external use only. flammable: keep away from fire or flame. do not use: with electrocautery, in the eyes stop use if irritation and redness develop. if condition persists for more than 72 hours, consult your doctor. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings: for external use only. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. if unusual redness, swelling or other symptoms occur, consult a physician immediately. do not use: in the eyes, or over large areas of the body.
Warnings: for external use only. do not use: in eyes, on broken skin, deep puncture wounds. if unusual redness,swelling, irritation or other symptoms occur, consult a physician immediately. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. flammable - keep away from fire or flame. avoid contact with eyes. if this happens, rinse thoroughly with water.
Dosage and Administration:
Directions ⢠clean the affected area. ⢠apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. ⢠may be covered with a sterile bandage.
Directions clean the affected area adults and children 2 years of age and older: apply a small amount of this product to affected area not more than 3 times daily children under 2 years of age: consult a doctor may be covered with a sterile bandage
Directions: wipe injection site vigorously and discard.
Directions: tear open packet, unfold towelette and use to cleanse desired skin area. discard towelette appropriately after single use.
Stop Use:
Stop use and ask a doctor if ⢠the condition persists or gets worse ⢠a rash or other allergic reaction develops.
Stop use and ask a doctor if ⢠the condition persists or gets worse ⢠symptoms persist for more than 7 days or clear up and occur again within a few days
Stop use if irritation and redness develop. if condition persists for more than 72 hours, consult your doctor.
Package Label Principal Display Panel:
Package labeling: kit kit2
First aid antibiotic ointment, 0.9g first aid antibiotic
First aid antiseptic pain relieving cream, 0.9g first aid antiseptic pain
Alcohol cleansing pad alcohol cleansing pad
Antiseptic towelette antiseptic towelette
Insect sting relief pad insect sting relief pad