FDA.reportPublic FDA data

ARU GUM HEALTH

Manufacturer
Ashtel Studios, Inc.
Effective date
2026-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:36:03

Label at a glance#

ProductARU GUM HEALTH
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Indications and uses

Aids in the prevention of cavities Helps prevent gingivitis Helps control plaque bacteria that contributes to the development of gingivitis. Helps interfere with the harmful effects of plaque associated with gingivitis

Dosage and administration

Adults and children 3 years and older : brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. Children under 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. Children under 2 years of age: Consult a dentist or doctor.

Storage and handling

Products containing stannous fluoride may produce surface staining of the teeth Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.454% 
(0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity, Antigingivitis

Uses

INDICATIONS & USAGE SECTION

  • Aids in the prevention of cavities
  • Helps prevent gingivitis
  • Helps control plaque bacteria that contributes to the development of gingivitis.
  • Helps interfere with the harmful effects of plaque associated with gingivitis

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 3 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • Do not swallow.
  • Children under 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
  • Children under 2 years of age: Consult a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

  • Products containing stannous fluoride may produce surface staining of the teeth
  • Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Aqua (Water), Cocamidopropyl Betaine, Flavor, Cellulose Gum, Potassium Sorbate, Stevia Rebaudiana Leaf Extract.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

9 INGREDIENTS

SOOTHING MINT

WE DON'T DO SECRETS.

EVERY INGREDIENT IS DECODED HERE.

DESIGNED IN U.S.A. • MADE IN INDIA

GETARU.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ARUGUMHEALTHARUGUMHEALTH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN2
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD2
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codegetaru.com/products/gum-health-toothpaste70108288-2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-288-01ARU GUM HEALTH99 g in 1 TUBEPASTE, DENTIFRICE992
70108-288-01ARU GUM HEALTH1 in 1 BOXPASTE, DENTIFRICE12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-28870108-288-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
STEVIA REBAUDIANA LEAF6TC6NN0876IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARU GUM HEALTHSTANNOUS FLUORIDEAshtel Studios, Inc.d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32026-01-30WarningsExact identifier
ndc (package): 70108-288-01
ndc (product): 70108-288
ndc11 (package): 70108028801
spl id: e245c687-e34c-4972-8cc6-1a3203613ce6
spl set id: d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.