Purpose
Sodium fluoride 0.24% (0.14% w/v fluoride ion)............................................................................................Anticavity
Act Anticavity Fluoride Kids Wild Watermelon Paste
FDA Label NDC 41167-0924
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Act Anticavity Fluoride Kids Wild Watermelon (NDC 41167-0924). 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 purpose, use, keep out of reach of children under 6 years of age., directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
■ aids in the prevention of dental cavities
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 of age | instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision. |
| children under 2 years of age | do not use unless directed by a dentist or doctor |
Other Information
■ contains FD&C yellow no. 5 (tartrazine) as a color additive
Inactive Ingredients
water, sorbitol, hydrated silica, hydroxyethylcellulose, flavor, sucralose, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, yellow 5, green 3
Principal Display Panel
ACT
Kids
wild
water-
melon
NET WT 4.6 oz (130 g)
Principal Display Panelactkidswildwater-melonnet Wt 4.6 Oz (130 G) (Act Anticavity Fluoride Toothpaste Kids Wild Water 01)
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