Kids Prime Pediatric Dental Group Anticavity For Kids Ointment
FDA Label NDC 87053-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Tooth Care Llc for the product Kids Prime Pediatric Dental Group Anticavity For Kids (NDC 87053-008). 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 drug facts, active ingredient, purpose, use, warnings, keep out of reach of children under 6 years of age., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.25%
Purpose
Anticavity
Use
helps protect against cavities
Warnings
Keep Out Of Reach Of Children Under 6 Years Of Age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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 2 to 6 years | Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) |
| Children under 2 years | Ask a dentist or physician |
Inactive Ingredients
Sorbitol, Aqua, Hydrated Silica, PEG-300, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Carrageenan, Saccharin Sodium, Sodium Pyrophosphate, FD&C Blue No.1.
Other Information
Store in a cool place, below 86°F, away from heat
Do not use if quality seal is broken or missing
Do not use after the expiration date
Package Labeling: 25G
Label0 (Label0)
Package Labeling: 50G
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