Active Ingredient
Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)
Oralline Gel, Dentifrice
FDA Label NDC 55873-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by J.m. Murray Center Inc. for the product Oralline (NDC 55873-002). 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 active ingredient, inactive ingredients, purpose, use, directions, warnings, keep out of reach of children, product labels, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Sorbitol, Hydrated Silica, DI Water, Glycerin, PEG 12, Sodium Lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Sodium Saccharin, FD C Blue 1
Purpose
Anticavity Toothpaste
Use
Use - Helps protect against cavities
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
If you accidentally swallow more than used for brushing get medical help or contact a poison control center immediately.
Keep Out Of Reach Of Children
Children under 2 years of age consult a doctor or a dentist
Keep out of the reach of children under 6 years of age.
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)
Oraline Secure Label (Murray Oraline Fluoride)
Oraline Label (Murray Oraline Fluoride Clear)
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