Mouth Oral Shield Spray

Manufacturer
Nutralife Biosciences, Inc.
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:45

Label at a glance#

ProductMouth Oral Shield
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure7 sections

Indications and uses

Helps prevent and reduce: plaque gingivitis

Dosage and administration

Shake well before use Apply 2 sprays directly into mouth Use up to 3 times daily

Storage and handling

Store at room temperature. Cold weather may cloud this product. Its antiseptic properties are not affected

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092% Menthol 0.042% Methyl Salicylate 0.060% Thymol 0.064%

OTC - PURPOSE SECTION

Active ingredientsPurposes
Eucalyptol 0.092% }

Menthol 0.042% }

Methyl salicylate 0.060% }

Thymol 0.064% }
Antiplaque/antigingivitis

Uses

INDICATIONS & USAGE SECTION

Helps prevent and reduce:

  • plaque
  • gingivitis

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

in children under 12 years of age

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature.
  • Cold weather may cloud this product. Its antiseptic properties are not affected

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • Apply 2 sprays directly into mouth
  • Use up to 3 times daily

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol (21.6%), Xylitol, Poloxamer 407, Vitamin C Citrus Bioflavonoid Complex, Mint Flavor, Sucralose, Potassium Sorbate, Zinc Chloride, Beta Cyclodextrin, FD&C Green 3

Mouth Oral Shield Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73761-104-022022-01-28C16284748780-1d6a99b39-662f-a426-e053-dadaa90af4c2Mouth Oral Shield Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73761-104-02Mouth Oral Shield60 mL in 1 BOTTLESPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73761-104MOUTH ORAL SHIELD (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) SPRAY [NUTRALIFE BIOSCIENCES, INC.]1Legacy NDC, 1 package rows20201208_b5e317c8-4c1b-1af9-e053-2a95a90a8a91.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73761-10473761-104-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
b5e317db-0117-6698-e053-2a95a90aa657b5e317c8-4c1b-1af9-e053-2a95a90a8a912020-12-07WarningsExact identifier
spl id: b5e317db-0117-6698-e053-2a95a90aa657
spl set id: b5e317c8-4c1b-1af9-e053-2a95a90a8a91

Reported adverse events (FAERS/openFDA)#

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