ORALLINE KIDS- sodium fluoride gel, dentifrice 
J.M. Murray Center Inc.

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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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

OraLine Kids Berry Label

OraLine Kids BG1 Label

OraLine Kids BG2 Label

res

ORALLINE KIDS 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55873-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55873-003-01113.4 g in 1 TUBE; Type 0: Not a Combination Product01/01/1966
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55873-004-01113.4 g in 1 TUBE; Type 0: Not a Combination Product01/01/1966
2NDC:55873-004-0285 g in 1 TUBE; Type 0: Not a Combination Product01/01/1966
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/FEIBusiness Operations
J.M. Murray Center Inc.071601108repack(55873-003, 55873-004) , relabel(55873-003, 55873-004)

Revised: 2/2019
Document Id: 06edc5b7-139f-4365-bfc4-c61a7ac97e27
Set id: 12c5bee5-e228-4f71-9bfd-c377ee2372a9
Version: 2
Effective Time: 20190225
 
J.M. Murray Center Inc.