Other
FLUORIDE gel TOOTHPASTE
Amerfresh Clear
FDA Label NDC 51460-5010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amercare Products Inc for the product Amerfresh Clear (NDC 51460-5010). 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 other, active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredient, principal display panel - 181 g carton label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Fluoride 0.22% (0.1% w/v fluoride ion)
Purpose
Anticavity
Use
helps protect against cavities.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children under 6 years of age.
If more than used for brushing is accidently swallowed, get medical help or contact a poison control centre immediately.
Directions
| Adults and children 6 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 a physician. |
| 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 Ingredient
Sorbitol, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin, Treated water, SCMC, Sodium Lauryl Sulfate.
Principal Display Panel - 181 G Carton Label
AMERFRESH®
FLUORIDE gel TOOTHPASTE
NET WT. 6.4 oz (181g)
Principal Display Panel (181 g Carton Label)
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