NDC 0135-0619 Aquafresh Kids Cavity Protection

NDC Product Code 0135-0619

NDC 0135-0619-01

Package Description: 130.4 g in 1 CANISTER

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Aquafresh Kids Cavity Protection with NDC 0135-0619 is a product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Aquafresh Kids Cavity Protection is . The product's dosage form is and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: -

Product Type: 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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • CARRAGEENAN CALCIUM (UNII: 5C4SQ0541D)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Labeler Information

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

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
Start Marketing Date: 09-01-2017 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: I 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.

Aquafresh Kids Cavity Protection Product Label Images

Aquafresh Kids Cavity Protection 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 0.84% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

  • •aids in the prevention of dental cavities.

When Using This Product,

If irritation occurs discontinue use.

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 and older: •apply toothpaste onto a toothbrush. •brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. •to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established. •children under 2 years of age: Consult a dentist or doctor.

Other Information

  • •Do not store above 25°C (77°F)

Inactive Ingredients (Bubble Mint)

Water, sorbitol, calcium carbonate, hydrated silica, glycerin, PEG-8, flavor, titanium dioxide, sodium lauryl sulfate, cellulose gum, sodium bicarbonate, sodium saccharin, calcium carrageenan, red 30, blue 1

* Please review the disclaimer below.