Label: DARBY APF STRAWBERRY- sodium fluoride aerosol, foam
DARBY APF MINT- sodium fluoride aerosol, foam
DARBY APF BUBBLE GUM- sodium fluoride aerosol, foam
- NDC Code(s): 66467-8003-2, 66467-8004-2, 66467-8005-2
- Packager: Darby Dental Supply, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Strawberry
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Directions For Use
l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.
- Medical Ingredients
- Warnings
- SPL UNCLASSIFIED SECTION
- Mint
-
Directions For Use
l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.
- Medical Ingredients
- Warnings
- SPL UNCLASSIFIED SECTION
- Bubble Gum
-
Directions For Use
l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.
- Medical Ingredients
- Warnings
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 125 g Can Label - Strawberry
- PRINCIPAL DISPLAY PANEL - 125 g Can Label - Mint
- PRINCIPAL DISPLAY PANEL - 125 g Can Label - Bubble Gum
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INGREDIENTS AND APPEARANCE
DARBY APF STRAWBERRY
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-8003 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) SODIUM FLUORIDE 2.72 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Sucralose (UNII: 96K6UQ3ZD4) Xylitol (UNII: VCQ006KQ1E) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) STRAWBERRY (UNII: 4J2TY8Y81V) POLOXAMER 407 (UNII: TUF2IVW3M2) Product Characteristics Color WHITE Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66467-8003-2 125 g in 1 CAN; Type 0: Not a Combination Product 10/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/29/2019 DARBY APF MINT
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-8004 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) SODIUM FLUORIDE 2.72 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Sucralose (UNII: 96K6UQ3ZD4) Xylitol (UNII: VCQ006KQ1E) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) Peppermint Oil (UNII: AV092KU4JH) Spearmint Oil (UNII: C3M81465G5) POLOXAMER 407 (UNII: TUF2IVW3M2) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66467-8004-2 125 g in 1 CAN; Type 0: Not a Combination Product 10/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/29/2019 DARBY APF BUBBLE GUM
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-8005 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) SODIUM FLUORIDE 2.72 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Sucralose (UNII: 96K6UQ3ZD4) Xylitol (UNII: VCQ006KQ1E) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) METHYL SALICYLATE (UNII: LAV5U5022Y) POLOXAMER 407 (UNII: TUF2IVW3M2) Product Characteristics Color WHITE Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66467-8005-2 125 g in 1 CAN; Type 0: Not a Combination Product 10/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/29/2019 Labeler - Darby Dental Supply, LLC (825137818)
