ANCALIMA-GOOD MORNING- sodium monofluorophosphate paste, dentifrice 
Ancalima

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.

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Ancalima- Good morning

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

Anticavity Toothpaste

Use

aids in the prevention of dental cavities

Warnings

Keep out of the 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 immediately

Directions

Other Information

Inactive Ingredients

Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Sodium Carboxymethyl Cellulose, Flavor, Sodium Saccharin, Sodium Methyl Paraben, Sodium Propyl Paraben

PRINCIPAL DISPLAY PANEL - 43 g Tube Carton


Principal Display

ANCALIMA-GOOD MORNING 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73014-1073
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73014-1073-643 g in 1 TUBE; Type 0: Not a Combination Product01/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/15/2015
Labeler - Ancalima (676760093)
Establishment
NameAddressID/FEIBusiness Operations
ANCALIMA LIFESCIENCES LIMITED676760093manufacture(73014-1073)

Revised: 5/2021
Document Id: c2b1f15a-d755-90fa-e053-2a95a90ab69e
Set id: c2b1f15a-d754-90fa-e053-2a95a90ab69e
Version: 1
Effective Time: 20210519
 
Ancalima