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OralLine Kids

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE .24g in 100g
Labeler: J.M. Murray Center Inc.
NDC Code: 55873-003

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.

Active Ingredient

Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)

Inactive Ingredients

Sorbitol, Hydrated Silica, DI Water, Glycerin, PEG 12, Sodium Lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Sodium Saccharin, FD C Blue 1

Purpose

Anticavity Toothpaste

Use

Use - Helps protect against cavities

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. 

Children under 6 years of age.  Use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing.  Supervise children as necessary until capable of using without supervision.

Warnings

If you accidentally swallow more than used for brushing get medical help or contact a poison control center immediately.

Keep Out of Reach of Children

Children under 2 years of age consult a doctor or a dentist

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

Product Labels
OraLine Kids Fluoride Toothpaste  ADA accepted.The ADA Council on Scientific Affairs Acceptance of OraLine Fluoride Mint Toothpaste is based on finding that the product is effective in helping to prevent and reduce tooth decay when used as directed

No animal based ingredients.  Mint Flavor  Net Wt



ORALLINE KIDS 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55873-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (SODIUM CATION) SODIUM FLUORIDE.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
WATER 
GLYCERIN 
POLYETHYLENE GLYCOL 600 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BENZOATE 
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55873-003-01113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1966
ORALLINE KIDS 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55873-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (SODIUM CATION) SODIUM FLUORIDE.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
WATER 
GLYCERIN 
POLYETHYLENE GLYCOL 600 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BENZOATE 
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 
SACCHARIN SODIUM 
FD&C RED NO. 40 
D&C RED NO. 33 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55873-004-01113.4 g in 1 TUBE
2NDC:55873-004-0285 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1966
Labeler - J.M. Murray Center Inc. (071601108)
Registrant - J.M. Murray Center Inc. (071601108)
Establishment
NameAddressID/FEIOperations
J.M. Murray Center Inc.071601108repack, relabel

Revised: 01/2011
 
J.M. Murray Center Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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