Strawberry
FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.
Darby Apf Strawberry Aerosol, Foam
FDA Label NDC 66467-8003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Darby Dental Supply, Llc for the product Darby Apf Strawberry (NDC 66467-8003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding strawberry, directions for use, medical ingredients, non-medical ingredients, warnings, other, mint, bubble gum, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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.
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
Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).
Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).
Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).
Non-Medical Ingredients
Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, strawberry flavor.
Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, mint flavor.
Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, bubble gum flavor.
Warnings
KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.
KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.
KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.
Other
To reorder: Call 800.645.2310 or visit darby.com
Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753
NDC 66467-8003∙2
Reorder# 9510050
1900196
To reorder: Call 800.645.2310 or visit darby.com
Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753
NDC 66467-8004∙2
Reorder# 9510051
1900197
To reorder: Call 800.645.2310 or visit darby.com
Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753
NDC 66467-8005∙2
Reorder# 9510052
1900198
Mint
FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.
Bubble Gum
FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.
Principal Display Panel - 125 G Can Label - Strawberry
darby
darby dental supply, llc
TOPICAL
FLUORIDE FOAM
2.72% TOPICAL SODIUM FLUORIDE FOAM
1.23% FLUORIDE IONS
130 Applications | 4.4 oz (125 g)
Strawberry
Principal Display Panel (125 g Can Label)
Principal Display Panel - 125 G Can Label - Mint
darby
darby dental supply, llc
TOPICAL
FLUORIDE FOAM
2.72% TOPICAL SODIUM FLUORIDE FOAM
1.23% FLUORIDE IONS
130 Applications | 4.4 oz (125 g)
Mint
Principal Display Panel (125 g Can Label)
Principal Display Panel - 125 G Can Label - Bubble Gum
darby
darby dental supply, llc
TOPICAL
FLUORIDE FOAM
2.72% TOPICAL SODIUM FLUORIDE FOAM
1.23% FLUORIDE IONS
130 Applications | 4.4 oz (125 g)
Bubble Gum
Principal Display Panel (125 g Can Label)
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