Active Ingredient
Sodium fluoride 0.24% (0.14% w/v fluoride ion)
Act Kids Anticavity Fluoride Groovy Grape Paste, Dentifrice
FDA Label NDC 41167-0926
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 Kids Anticavity Fluoride Groovy Grape (NDC 41167-0926). 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, purpose, use, keep out of the reach of children under 6 years of age., directions, 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
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Keep Out Of The 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 | consult a dentist or doctor |
Inactive Ingredients
water, sorbitol, hydrated silica, hydroxyethylcellulose, flavor, sucralose, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, red 33, blue 1
Principal Display Panel
ACT
Kids
NEW
ANTICAVITY
FLUORIDE
TOOTHPASTE
GROOVY
Grape
NET WT 4.6 OZ (130 g)
Actkidsnewanticavityfluoridetoothpastegroovygrapenet Wt 4.6 Oz (130 G) (Act Kids Anticavity Fluoride Toothpaste Groovy Gra 01)
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