NDC 44019-400 Baby Wipes With Allantoin

Allantoin

NDC Product Code 44019-400

NDC 44019-400-80

Package Description: 360 g in 1 BAG

NDC Product Information

Baby Wipes With Allantoin with NDC 44019-400 is a a human over the counter drug product labeled by Yinjing Medical Technology (shanghai) Co., Ltd.. The generic name of Baby Wipes With Allantoin is allantoin. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Yinjing Medical Technology (shanghai) Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Baby Wipes With Allantoin Active Ingredient(s)

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

  • ALLANTOIN .5 g/100g

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.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)

Administration Route(s)

What 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.
  • 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

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

Labeler Name: Yinjing Medical Technology (shanghai) Co., Ltd.
Labeler Code: 44019
FDA Application Number: part347 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-03-2016 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.

Baby Wipes With Allantoin Product Label Images

Baby Wipes With Allantoin 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

Otc - Active Ingredient

Allantoin 0.5%(w/w)

Otc - Purpose

Skin Protectant

Uses:

Temporarily protects and helps relieve minor skin irritations

Warnings:

For external use only.

When Using This Product, Do Not Get Into Eyes.

Stop use and ask a doctor if the rash persists for more than 7 days,


or tends to reoccur. Keep out of reach of children

Stop Use And Ask A Doctor

If rash persists for more than 7 days, or tends to reoccur.

Directions

  • Open lid, remove tab ans pull wipe through Take wipe and rub thoroughly over the affected area
  • Use as many wipes as needed
  • DO NOT FLUSH,dispose of used wipes in trash

Inactive Ingredients:

Water, Propylene Glycol, Polysorbate-20, Chamomilla Recutita Water, Tocopheryl acetate, Benzalkonium chloride, Aloe barbadensis leaf juice, potassium sorbate, Sodium Benzoate, Gluconolactone.

Other Information:

Store in a cool dry place

* Please review the disclaimer below.