NDC 72663-140 Welly Superhero Supplies Kit

Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride, Hydrocortisone

NDC Product Code 72663-140

NDC Code: 72663-140

Proprietary Name: Welly Superhero Supplies Kit 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.

Non-Proprietary Name: Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride, Hydrocortisone What 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.

NDC Code Structure

  • 72663 - Welly Health Pbc
    • 72663-140 - Welly Superhero Supplies Kit

NDC 72663-140-32

Package Description: 1 KIT in 1 KIT * .5 mL in 1 POUCH * .9 mL in 1 POUCH * .9 mL in 1 POUCH * .9 mL in 1 POUCH

NDC Product Information

Welly Superhero Supplies Kit with NDC 72663-140 is a a human over the counter drug product labeled by Welly Health Pbc. The generic name of Welly Superhero Supplies Kit is alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hydrochloride, hydrocortisone. The product's dosage form is kit and is administered via form.

Labeler Name: Welly Health Pbc

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
  • ALCOHOL (UNII: 3K9958V90M)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • WHITE WAX (UNII: 7G1J5DA97F)

Product Labeler Information

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

Labeler Name: Welly Health Pbc
Labeler Code: 72663
FDA Application Number: part333E 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-01-2019 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.

Welly Superhero Supplies Kit Product Label Images

Welly Superhero Supplies Kit 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

Instant Hand Sanitizer Gel

Drug Facts

Active Ingredient

Ethyl Alcohol 66.5%

Lidocaine HCl 2.0%

Hydrocortisone 1.0%

Purpose

Antiseptic

First Aid Antibiotics

Topical pain relief

Anti-itch

Use

For handwashing to decrease bacteria on skin without soap and water.

Warnings

For external use onlyFlammable, keep away from fire or flame.Do not use in eyes, if this happens, rinse thoroughly with water.Stop use, ask a doctor if, irritation develops and persists for 72 hours.

  • For external use onlyDo not use:internallyin eyesover large areas of the body or on puncture wounds, animal bites or serious burnsfor more than 1 week unless directed by a doctorif you are allergic to any of the ingredientsStop use and ask a doctor ifa rash or allergic reactions developscondition worsens or persists

  • External use onlyDo not usenear eyes, if this happens, rinse thoroughly with waterin large quantities, particularly over raw or blistered areasStop use, ask doctor if conditions worsen or last more than 7 days or clears up and returns.

  • For external use onlyDo not usein eyesfor treatment of diaper rashfor feminine itchingStop use, ask a doctorif condition worsens or lasts more than 7 days, or clears up and occurs again within a few dayswith use of other hydrocortisone products

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If ingested, contact a Poison Control Center right away.

Keep out of reach of children. If ingested contact a Poison Control Center directly

Keep out of reach of children. If ingested, contact a Poison Control Center right away

Directions

  • Wet hands & wrists thoroughly with product and allow to dry without wiping

  • Clean affected areaapply a small amount 1 to 3 times dailymay cover with a sterile bandage

  • Adults and children 2 years and older: apply to affected area not more than 3 to 4 times dailychildren under 2: do not use, ask a doctor

  • Apply to affected area not more than 3 to 4 times dailychildren under 2: ask a doctor

Inactive Ingredients

Aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

Petrolatum

Aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Triple Antibiotic Ointment

Drug Facts

Active Ingredient (In Each Gram)

Bacitracin zinc 400 unitsNeomycin sulfate (3.5mg Neomycin)Polymyxin B sulfate 5000 units

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Temporary pain relief for minor burns

  • For temporary relief of itching associated with minor skin irritations, inflammation, or rashes.Other uses of product should be only under the advice and supervision of a doctor.

Burn Gel

Drug Facts

1% Hydrocortisone Cream

Drug Facts

* Please review the disclaimer below.

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