NDC 73314-001 Little Twig 8.5 Oz Oat Babywash

Colloidal Oatmeal

NDC Product Code 73314-001

NDC 73314-001-08

Package Description: 251 mL in 1 BOTTLE

NDC Product Information

Little Twig 8.5 Oz Oat Babywash with NDC 73314-001 is a a human over the counter drug product labeled by Kittrich Corporation. The generic name of Little Twig 8.5 Oz Oat Babywash is colloidal oatmeal. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Kittrich Corporation

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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.

Little Twig 8.5 Oz Oat Babywash 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.

  • OATMEAL 1 g/100mL

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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
  • SOLANUM LYCOPERSICUM (UNII: 0243Q4990L)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79)
  • SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
  • ALLANTOIN (UNII: 344S277G0Z)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.

Product Labeler Information

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

Labeler Name: Kittrich Corporation
Labeler Code: 73314
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: 09-01-2019 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.

Little Twig 8.5 Oz Oat Babywash Product Label Images

Little Twig 8.5 Oz Oat Babywash 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 Ingredient

Active IngredientColloidal Oatmeal 1%

Purpose

Purpose:Skin Protectant

Warnings

Warnings: For external use only.

Keep Out Of Reach Of Children

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

Inactive Ingredients

Purified Water (Aqua), Decyl Glucoside, Sodium Cocomphoacetate, Lauryl Glucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glycol Carboxylate, Glycerin, Xanthan Gum, Aloe Barbandensis (Aloe Vera) Leaf Juice, Lavandula Angustifolia (Lavender) Extract, Calendula Officinalis (Calendula) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis (White Tea) Leaf Extract, Anthemis Nobilis Flower Extract, Rosmarinus Officinalis (Rosemarry ) Leaf Extract, Solanum Lycopersicum (Tomato) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Persea Gratissima (Avocado) Oil, Quillaja Saponaria (Quillaia) Bark Extract, Butyrospermum Parkii (Shea) Butter, Sodium Lauroyl Glutamate, Allantoin, Polysorbate 20, Citric Acid, Potassium Sorbate, Ethylhexylglycerin, Phenethyl Alcohol,Caprylhydroxamic Acid.

Directions

Directions: Apply as needed.

Instructions For Use

When using this product do not get into eyes.

Stop Use And Ask A Doctor

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Indications & Usage

Uses:Temporarily protects and helps relieve minor skin irritation and itching due to: Eczema, Rashes, Poison Ivy, Insect Bites.

* Please review the disclaimer below.