United Airlines Polaris Kit

United Airlines Polaris Kit
SPL v4
SPL
SPL Set ID d31dd3b7-e669-6506-e053-2995a90a03d0
Routes
DENTAL TOPICAL
Published
Effective Date 2021-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg) Alcohol (75 mL)
Inactive Ingredients
Dibasic Calcium Phosphate Dihydrate Water Sorbitol Sodium Lauryl Sulfate Methyl Salicylate Carboxymethylcellulose Sodium, Unspecified Sodium Pyrophosphate Saccharin Sodium Glycerin Tea Tree Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-15

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

Uses
  • To help reduce bacteria on the skin.
Warnings
  • For external use only.
  • Do not dispose of wipes in flush toilets. 
  • Keep away from fire or flame.

Flammable

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's brushing and rinsing (to minimize swallowing)
 children under 2 years  ask a dentist or physician

Drug Facts

Active Ingredient

Ethyl Alcohol 75% (v/v)

Active Ingredient

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

Other Information
  • Store below 110°F (43°C).
  • May discolor certain fabrics or surfaces.
Inactive Ingredients

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

Questions Or Comments?

Call to-free 1-800-468-6502

When Using This Product
  • avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.
Keep Out of Reach of Children
  • In case of accidental ingestion, get medical help or contact a poison control center immediately.
Package Labeling:42555 060 94

Package Labeling:69491 035 01

Package Labeling:69491 036 01

Stop Using and Ask A Doctor If
  • irritation or redness develops and lasts.
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

Uses
  • To help reduce bacteria on the skin.
Purpose

Anticavity

Warnings
  • For external use only.
  • Do not dispose of wipes in flush toilets. 
  • Keep away from fire or flame.

Flammable

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's brushing and rinsing (to minimize swallowing)
 children under 2 years  ask a dentist or physician

Drug Facts

Active Ingredient

Ethyl Alcohol 75% (v/v)

Active Ingredient (Active ingredient)

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

Other Information
  • Store below 110°F (43°C).
  • May discolor certain fabrics or surfaces.
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 to-free 1-800-468-6502

When Using This Product (When using this product)
  • avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.
Keep Out of Reach of Children (Keep out of reach of children)
  • In case of accidental ingestion, get medical help or contact a poison control center immediately.
Package Labeling:42555 060 94 (Package Labeling:42555-060-94)

Package Labeling:69491 035 01 (Package Labeling:69491-035-01)

Package Labeling:69491 036 01 (Package Labeling:69491-036-01)

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)
  • irritation or redness develops and lasts.
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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