White-Glo 2in1 with Mouthwash: Package Insert and Label Information

WHITE-GLO 2IN1 WITH MOUTHWASH- sodium monofluorophosphate paste
HUAIAN ZONGHENG BIO-TECH CO., LTD

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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:71167-002 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 0.76 g in 100 g

Inactive Ingredients Ingredient Name Strength 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 Code Package Description Multilevel Packaging 1 NDC:71167-002-01 24 TUBE in 1 BOX contains a TUBE 1 150 g in 1 TUBE This package is contained within the BOX (71167-002-01) 2 NDC:71167-002-02 48 TUBE in 1 BOX contains a TUBE 2 150 g in 1 TUBE This package is contained within the BOX (71167-002-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/10/2016

Labeler — HUAIAN ZONGHENG BIO-TECH CO., LTD (527152733)

Establishment
Name	Address	ID/FEI	Operations
HUAIAN ZONGHENG BIO-TECH CO., LTD		527152733	manufacture (71167-002)

Revised: 03/2017 HUAIAN ZONGHENG BIO-TECH CO., LTD