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

Purpose

Anticavity 

Description

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


Medication Information

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

Inactive Ingredients

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

Description

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

Use

helps protect against cavities

Drug Facts

Active Ingredient

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

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

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

Inactive Ingredients (Inactive ingredients)

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

Use

helps protect against cavities

Drug Facts

Active Ingredient (Active ingredient)

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

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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