Ua Main Cabin Hawaii Premium Kit 2020 W Colgate Toothpaste

Ua Main Cabin Hawaii Premium Kit 2020 W Colgate Toothpaste
SPL v1
SPL
SPL Set ID 9fe37663-4066-a787-e053-2995a90ac1a4
Route
DENTAL
Published
Effective Date 2020-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Dibasic Calcium Phosphate Dihydrate Water Sorbitol Sodium Lauryl Sulfate Methyl Salicylate Carboxymethylcellulose Sodium, Unspecified Form Sodium Pyrophosphate Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-03-13

Description

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

Purpose

Anticavity 


Medication Information

Purpose

Anticavity 

Description

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

Use

helps protect against cavities

Directions
 adults and children 2 years of age and older   brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
 children 2 to 6 years  use only a pea sized amount and supervise child brushing and rinsing (to minimize swallowing)
 children under 2 years  ask a dentist or physician

Drug Facts

Active Ingredient

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

Inactive Ingredients

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

Questions Or Comments?

Call toll-free 1-800-492-7378

Package Labeling: (69491 235 00)

Package Labeling: (69491 060 94)

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.


Structured Label Content

Use

helps protect against cavities

Purpose

Anticavity 

Directions
 adults and children 2 years of age and older   brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
 children 2 to 6 years  use only a pea sized amount and supervise child brushing and rinsing (to minimize swallowing)
 children under 2 years  ask a dentist or physician

Drug Facts

Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-492-7378

Package Labeling: (69491 235 00) (Package Labeling: (69491-235-00))

Package Labeling: (69491 060 94) (Package Labeling: (69491-060-94))

Keep Out of the Reach of Children Under 6 Years of Age. (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.


Advanced Ingredient Data


Raw Label Data

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