FDA.reportPublic FDA data

Shopkins Mouth wash

Manufacturer
Ashtel Studios Inc. | Dabur India Limited
Effective date
2019-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:38

Label at a glance#

ProductShopkins Mouth wash
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Anticavity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental digestion seek professional assistance or contact a poison control center immediately.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Sodium Fluoride 0.5% (0.23% w/v fluoride ion) ......................... Anticavity

INDICATIONS & USAGE SECTION

Helps protect teeth and roots against cavities

WARNINGS SECTION

keep out of reach of children.

If you accidentally swallow seek medical help or contact a poison control center immediately

INACTIVE INGREDIENT SECTION

Water, Glycerine,PEG-40 Hydrogenated Castor Oil,Propylene Glycol,Xylitol,Benzyl Alcohol, Flavor, Sodium Benzoate, Sodium Saccharin, Zinc Gluconate, FD&C Red 40, D&C Red 33

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and older:
Use daily after your normal brushing. Rinse toothpaste from your mouth prior to ouse.

Rinse or gargle for 30 seconds with 15ml (3 teaspoonful) and then spit it out.

Do not swallow the mouth wash

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-008-012025-01-30C16284748780-12cef2736-999a-d83d-e063-dadaa90ab31fShopkins Mouth wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-008-01Shopkins Mouth wash479 g in 1 TUBELIQUID4792

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-008SHOPKINS MOUTH WASH (SODIUM FLUORIDE) LIQUID [ASHTEL STUDIOS INC.]2Legacy NDC, 1 package rows20200101_3e370570-32f6-3466-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-00870108-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CITRAL PROPYLENE GLYCOL ACETAL9W7YHX7EX6IACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEB70850QPHRIACT
WATER059QF0KO0RIACT
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL HYDROCHLORIDE, ERYTHRO-(+/-)-3IIJ9C722IIACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
25a7fd21-6967-4450-a8e9-f3a4f8a490ba3e370570-32f6-3466-e054-00144ff8d46c2019-12-31WarningsExact identifier
spl id: 25a7fd21-6967-4450-a8e9-f3a4f8a490ba
spl set id: 3e370570-32f6-3466-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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