Label: ORALLINE SECURE- sodium fluoride paste, dentifrice
ORALLINE- sodium fluoride gel, dentifrice
- NDC Code(s): 55873-001-01, 55873-002-01
- Packager: J.M. Murray Center Inc.
- Category: HUMAN OTC DRUG LABEL
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 23, 2019
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- Official Label (Printer Friendly)
- Active Ingredient
- Inactive Ingredients
- Purpose
- Use
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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
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Product Labels
OraLine 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 3 oz (85 g)
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INGREDIENTS AND APPEARANCE
ORALLINE SECURE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55873-001 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:55873-001-01 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 ORALLINE
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55873-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION .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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:55873-002-01 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(55873-001, 55873-002) , relabel(55873-001, 55873-002) Establishment Name Address ID/FEI Business Operations Dental Technologies, Inc. 148312838 manufacture(55873-001, 55873-002)