NDC 72135-029 Hawaiian Airline Ec With Colgate Toothbrush And Sun

Sodium Monofluorophosphate, Zinc Oxide

NDC Product Code 72135-029

NDC CODE: 72135-029

Proprietary Name: Hawaiian Airline Ec With Colgate Toothbrush And Sun 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: Sodium Monofluorophosphate, Zinc Oxide 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.

Product Characteristics

Color(s):
WHITE (C48325)
Flavor(s):
MINT (C73404)

NDC Code Structure

  • 72135 - Luoding Quality Amenities Supply Limited
    • 72135-029 - Hawaiian Airline Ec With Colgate Toothbrush And Sun

NDC 72135-029-02

Package Description: 1 KIT in 1 KIT * 5 g in 1 TUBE (42555-060-94) * 4 g in 1 PACKET (70680-308-00)

NDC Product Information

Hawaiian Airline Ec With Colgate Toothbrush And Sun with NDC 72135-029 is a a human over the counter drug product labeled by Luoding Quality Amenities Supply Limited. The generic name of Hawaiian Airline Ec With Colgate Toothbrush And Sun is sodium monofluorophosphate, zinc oxide. The product's dosage form is kit and is administered via form.

Labeler Name: Luoding Quality Amenities Supply Limited

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.

  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • TOCOPHEROL (UNII: R0ZB2556P8)

Product Labeler Information

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

Labeler Name: Luoding Quality Amenities Supply Limited
Labeler Code: 72135
FDA Application Number: part352 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: 08-01-2019 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hawaiian Airline Ec With Colgate Toothbrush And Sun Product Label Images

Hawaiian Airline Ec With Colgate Toothbrush And Sun 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

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Sunscreen

Use

Helps protect against cavities

Keep Out Of The Reach Of Children Under 6 Years Of Age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physicianchildren 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)children under 2 yearsask a dentist or physician

Inactive Ingredients

Dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Active Ingredients

Zinc Oxide 23%

Uses:

Helps prevent sunburn

Warnings:

For external use only.

Do Not Use

On damaged or broken skin.

Stop Use And Ask A Doctor

If skin rash occurs.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating, Immediately after towel drying, at least every 2 hours. Children under 6 months: Ask a doctorSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

Camellia Sinensis Leaf Extract (Organic Green Tea), Camellia Sinensis Leaf Extract (Organic Black Tea), Cannabis Sativa Seed Oil (Organic Hemp Seed Oil), Cera Alba (Organic Beeswax), Coffea Arabica Seed Extract (Organic Coffee Bean), Helianthus Annuus Seed Oil (Organic Sunflower Oil), Mangifera Indica Seed Butter (Natural Mango Butter), Rosmarinus Officinalis Leaf Oil (Natural Rosemary), Theobroma Cacao Seed Butter (Organic Cocoa Butter), Tocopherol *Certified Organic

Other Information:

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.