FDA.reportPublic FDA data

White-Glo whiting tooth

Manufacturer
HUAIAN ZONGHENG BIO-TECH CO., LTD
Effective date
2018-02-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:21

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

sodium monofluorphosphate 0.76%

Purpose

Anticavitytoothpaste

Uses

Use

helps protect against cavities

Warnings

Warning

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

Directions And Dosage

Directions

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist. do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's burshing ntil good habits are established children under 2 years ask a dentist

Other Label Information

Inactive Ingredients

Calcium Carbonate,Aqua,Glycerin,Sorbitol,Silica,Aroma,Sodium Lauryl Sulphate,Carboxymethyl Hydroxyethyl cellulose,Chondrus Crispus,CI77891(Titanium Dioxide),Sodium saccharin,rose canina fruit oil

Label Images#

20180202144522
20180202144522

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71167-004-012020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-022020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-032020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-042020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-052020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-062020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-072020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-082020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-092020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-102020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71167-004-01White-Glo whiting tooth24 in 1 BOXPASTE241
71167-004-01White-Glo whiting tooth150 g in 1 TUBEPASTE1501
71167-004-02White-Glo whiting tooth48 in 1 BOXPASTE481
71167-004-02White-Glo whiting tooth150 g in 1 TUBEPASTE1501
71167-004-03White-Glo whiting tooth100 g in 1 TUBEPASTE1001
71167-004-03White-Glo whiting tooth24 in 1 BOXPASTE241
71167-004-04White-Glo whiting tooth48 in 1 BOXPASTE481
71167-004-04White-Glo whiting tooth100 g in 1 TUBEPASTE1001
71167-004-05White-Glo whiting tooth80 g in 1 TUBEPASTE801
71167-004-05White-Glo whiting tooth20 in 1 BOXPASTE201
71167-004-06White-Glo whiting tooth40 in 1 BOXPASTE401
71167-004-06White-Glo whiting tooth80 g in 1 TUBEPASTE801
71167-004-07White-Glo whiting tooth144 in 1 BOXPASTE1441
71167-004-07White-Glo whiting tooth50 g in 1 TUBEPASTE501
71167-004-08White-Glo whiting tooth100 in 1 BOXPASTE1001
71167-004-08White-Glo whiting tooth24 g in 1 TUBEPASTE241
71167-004-09White-Glo whiting tooth188 in 1 BOXPASTE1881
71167-004-09White-Glo whiting tooth24 g in 1 TUBEPASTE241
71167-004-10White-Glo whiting tooth1000 in 1 BOXPASTE10001
71167-004-10White-Glo whiting tooth12 g in 1 TUBEPASTE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71167-004WHITE-GLO WHITING TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE [HUAIAN ZONGHENG BIO-TECH CO., LTD]1Legacy NDC, 20 package rows20180202_64384dff-e2c6-2f96-e053-2a91aa0a9a5d.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71167-00471167-004-01, 71167-004-02, 71167-004-03, 71167-004-04, 71167-004-05, 71167-004-06, 71167-004-07, 71167-004-08, 71167-004-09, 71167-004-10

Ingredients#

Name, UNII, Kind table
NameUNIIKind
CHONDRUS CRISPUSOQS23HUA1XIACT
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL506T60A25RIACT
SODIUM SILICATEIJF18F77L3IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
POTASSIUM SODIUM SACCHARATE73U34YC90UIACT
ROSA CANINA FLOWER OILDUY7M48I1TIACT

Complete SPL Sections#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

sodium monofluorphosphate 0.76%

Purpose

OTC - PURPOSE SECTION

Anticavitytoothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

WARNINGS SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist. do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's burshing ntil good habits are established children under 2 years ask a dentist

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate,Aqua,Glycerin,Sorbitol,Silica,Aroma,Sodium Lauryl Sulphate,Carboxymethyl Hydroxyethyl cellulose,Chondrus Crispus,CI77891(Titanium Dioxide),Sodium saccharin,rose canina fruit oil

Keep out of reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

Source Document#

Source XML