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ATOMY PROPOLIS 50g

Dosage form: paste, dentifrice
Ingredients: Sodium Monofluorophosphate 0.08g, Sodium Fluoride 0.05g
Labeler: ATOMY CO., LTD.
NDC code: 52257-1310

ACTIVE INGREDIENT

Active Ingredient: Sodium Monofluorophosphate 0.16%, Sodium Fluoride 0.1%

INACTIVE INGREDIENT

Inactive Ingredients: Silicon dioxide, Sodium pyrophosphate, D-Sorbitol solution, Polyethylene glycol1500, Hydrated silicone dioxide, Carboxymethylcellulose, Sodium lauryl sulfate, Xylitol, Sodium saccharin, Green tea extract, Propolis extract, L-menthol, Orange oil, Mint flavour, Citrus flavour, Purified water

PURPOSE

Purpose: Anticaries

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.

DOSAGE & ADMINISTRATION

Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATOMY PROPOLIS  50G
sodium monofluorophosphate, sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1310
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (FLUORIDE ION) FLUORIDE ION0.08 g  in 4 
Sodium Fluoride (FLUORIDE ION) FLUORIDE ION0.05 g  in 4 
Inactive Ingredients
Ingredient NameStrength
Silicon dioxide 
Sodium pyrophosphate 
Packaging
#Item CodePackage Description
1NDC:52257-1310-14 PASTE, DENTIFRICE in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2015
Labeler - ATOMY CO., LTD. (631154601)
Registrant - ATOMY CO., LTD. (631154601)
Establishment
NameAddressID/FEIOperations
ATOMY CO., LTD.631154601repack(52257-1310)
Establishment
NameAddressID/FEIOperations
Kolmar Korea Co., Ltd.688732723manufacture(52257-1310)

Revised: 06/2015
 
ATOMY CO., LTD.

Further information

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