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White-Glo 2in1 with mouthwash by HUAIAN ZONGHENG BIO-TECH CO., LTD

Medically reviewed on Mar 22, 2017

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: HUAIAN ZONGHENG BIO-TECH CO., LTD
NDC Code: 71167-002

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

sodium monofluorphosphate  0.76%

Purpose

Anticavitytoothpaste

Use

helps protect against cavities

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

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

Calcium Carbonate,Aqua,Glycerin,denature alcohol(2.5%),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

Keep out of reach of children under 6 years of age

WHITE-GLO 2IN1 WITH MOUTHWASH 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71167-002
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHONDRUS CRISPUS 
CALCIUM CARBONATE 
WATER 
GLYCERIN 
TITANIUM DIOXIDE 
SORBITOL 
SODIUM SILICATE 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE 
POTASSIUM SODIUM SACCHARATE 
ROSA CANINA FLOWER OIL 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:71167-002-0124 TUBE in 1 BOX
1150 g in 1 TUBE
2NDC:71167-002-0248 TUBE in 1 BOX
2150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/10/2016
Labeler - HUAIAN ZONGHENG BIO-TECH CO., LTD (527152733)
Establishment
NameAddressID/FEIOperations
HUAIAN ZONGHENG BIO-TECH CO., LTD527152733manufacture(71167-002)

 
HUAIAN ZONGHENG BIO-TECH CO., LTD

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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