Label: WHITE-GLO WHITING TOOTH- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 71167-004-01, 71167-004-02, 71167-004-03, 71167-004-04, view more71167-004-05, 71167-004-06, 71167-004-07, 71167-004-08, 71167-004-09, 71167-004-10 - Packager: HUAIAN ZONGHENG BIO-TECH CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 2, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warning
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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
- Keep out of reach of children under 6 years of age
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WHITE-GLO WHITING TOOTH
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71167-004 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength CHONDRUS CRISPUS (UNII: OQS23HUA1X) CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL (UNII: 506T60A25R) SODIUM SILICATE (UNII: IJF18F77L3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71167-004-01 24 in 1 BOX 02/02/2018 1 150 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71167-004-02 48 in 1 BOX 02/02/2018 2 150 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:71167-004-03 24 in 1 BOX 02/02/2018 3 100 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:71167-004-04 48 in 1 BOX 02/02/2018 4 100 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:71167-004-05 20 in 1 BOX 02/02/2018 5 80 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:71167-004-06 40 in 1 BOX 02/02/2018 6 80 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:71167-004-07 144 in 1 BOX 02/02/2018 7 50 g in 1 TUBE; Type 0: Not a Combination Product 8 NDC:71167-004-08 100 in 1 BOX 02/02/2018 8 24 g in 1 TUBE; Type 0: Not a Combination Product 9 NDC:71167-004-09 188 in 1 BOX 02/02/2018 9 24 g in 1 TUBE; Type 0: Not a Combination Product 10 NDC:71167-004-10 1000 in 1 BOX 02/02/2018 10 12 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/02/2018 Labeler - HUAIAN ZONGHENG BIO-TECH CO., LTD (527152733) Establishment Name Address ID/FEI Business Operations HUAIAN ZONGHENG BIO-TECH CO., LTD 527152733 manufacture(71167-004)
