delta comfort plus - amenity kit

delta comfort plus - amenity kit
SPL v3
SPL
SPL Set ID 26434794-ae02-0f58-e063-6294a90ad85e
Route
dental
Published
Effective Date 2019-02-02
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 drug active Since 2019-04-01

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 apea sized amount and supervise child's 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?

1-800-492-7378

Colgate Anticavity 5g (42555 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.

Delta Comfort Plus 2019 Amenity Kit With Colgate Cavity Protection Toothpaste (69491 210 00)


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 apea sized amount and supervise child's 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?)

1-800-492-7378

Colgate Anticavity 5g (42555 060 94) (COLGATE ANTICAVITY 5g (42555-060-94))

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.

Delta Comfort Plus 2019 Amenity Kit With Colgate Cavity Protection Toothpaste (69491 210 00) (DELTA COMFORT PLUS 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste (69491-210-00))


Advanced Ingredient Data


Raw Label Data

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