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DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE

Medically reviewed on Dec 1, 2017

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76mL in 100mL
Labeler: DARPHIN DIST.
NDC Code: 16555-996

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.

WHITENING FORMULA
DENBLAN
ANTICAVITY FLUORIDE TOOTHPASTE

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76%

Purpose

Fluoride toothpaste

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as neccessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Ingredients

water, dicalcium phosphate, calcium carbonate, silica, glycerin, sorbitol, algin, carica papaya (papaya) fruit extract, ananas sativus (pineapple) fruit extract, mentha viridis (spearmint) leaf oil, mentha arvensis leaf oil, usnea barbata (lichen) extract, angelica archangelica root oil, carum petroselinum (parsley) seed oil, foeniculum vulgare (fennel) oil, sodium lauryl sulfate, propylene glycol, sodium saccharin, limonene, sodium benzoate, sodium propylparaben, sodium methylparaben <ILN36886>.

DARPHIN
LABORATORIES DARPHIN, Dist.

PRINCIPAL DISPLAY PANEL - 75mL Carton

WHITENING FORMULA
DENBLAN
ANTICAVITY FLUORIDE TOOTHPASTE

REFRESHING MINT TASTE

e 75mL
POIDS NET WT. 2.6 OZ.

DENBLAN   WHITENING FORMULA ANTI CAVITY FLUORIDE
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16555-996
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE0.76 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
SILICON DIOXIDE 
GLYCERIN 
SORBITOL 
PAPAYA 
PINEAPPLE 
SPEARMINT OIL 
MENTHA ARVENSIS LEAF OIL 
USNEA BARBATA 
ANGELICA ROOT OIL 
PARSLEY SEED OIL 
FENNEL OIL 
SODIUM LAURYL SULFATE 
PROPYLENE GLYCOL 
SACCHARIN SODIUM DIHYDRATE 
SODIUM BENZOATE 
PROPYLPARABEN SODIUM 
METHYLPARABEN SODIUM 
Packaging
#Item CodePackage Description
1NDC:16555-996-011 TUBE (TUBE) in 1 CARTON
175 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/01/2004
Labeler - DARPHIN DIST. (105157494)
Establishment
NameAddressID/FEIOperations
ELGC Kabushiki Kaisha712808195RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
ARAMIS, INC042918826MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE
Establishment
NameAddressID/FEIOperations
CCI Productions Parfums & Cosmetiques268298408MANUFACTURE

 
DARPHIN DIST.

Further information

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

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