American Airlilne Business Class Kit

American Airlilne Business Class Kit
SPL v10
SPL
SPL Set ID 483d7aec-34ac-49c5-ac0e-8fba5b4737ae
Route
DENTAL
Published
Effective Date 2019-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Calcium Phosphate, Dibasic, Dihydrate Water Sorbitol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Sodium Pyrophosphate Saccharin Sodium Limonene, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-09
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

Section 50565-1

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of the reach of children under 6 years of age.

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
Active Ingredient

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

Package Labeling:

Inactive Ingredients

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

Questions Or Comments?

Call toll-free 1-800-468-6502

Structured Label Content

Use

helps protect against cavities

Section 50565-1 (50565-1)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of the reach of children under 6 years of age.

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

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

Package Labeling:

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 1-800-468-6502

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:34.019922 · Updated: 2026-03-14T23:11:08.891584