Label: ORALLINE KIDS- sodium fluoride gel, dentifrice
-
Contains inactivated NDC Code(s)
NDC Code(s): 55873-003-01, 55873-004-01, 55873-004-02 - Packager: J.M. Murray Center Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 25, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Inactive Ingredients
- Purpose
- Use
-
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
- Keep Out of Reach of Children
- Product Labels
-
INGREDIENTS AND APPEARANCE
ORALLINE KIDS
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55873-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.15 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor MINT (MINT FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55873-003-01 113.4 g in 1 TUBE; Type 0: Not a Combination Product 01/01/1966 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1966 ORALLINE KIDS
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55873-004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.15 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor MINT (Mint Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55873-004-01 113.4 g in 1 TUBE; Type 0: Not a Combination Product 01/01/1966 2 NDC:55873-004-02 85 g in 1 TUBE; Type 0: Not a Combination Product 01/01/1966 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1966 Labeler - J.M. Murray Center Inc. (071601108) Registrant - J.M. Murray Center Inc. (071601108) Establishment Name Address ID/FEI Business Operations J.M. Murray Center Inc. 071601108 repack(55873-003, 55873-004) , relabel(55873-003, 55873-004)