Active Ingredient
Sodium fluoride 0.24%
Orajel Kidstoothpaste Paste, Dentifrice
FDA Label NDC 10237-785
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Orajel Kidstoothpaste (NDC 10237-785). 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, warnings, directions, inactive ingredients, questions or comments?, 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 toothpaste
Use
aids in the prevention of dental decay
Warnings
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.
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
- twist off cap and remove foil seal
- do not swallow
- supervise children as necessary until capable of using without supervision
- brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
- Instruct in good brushing and rinsing habits (to minimize swallowing)
- ask a dentist of physician
Adults and children 2 years and older
Children under 6 years
Children under 2 years
Inactive Ingredients
sorbitol, water, hydrated silica, PEG-8, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1
Questions Or Comments?
Call us at 800-952-5080 Monday through Friday 9 - 5 ET or visit our website at www.orajel.com
Principal Display Panel
Mixed Berry
Orajel
Anticavity
Fluoride
Toothpaste
magical unicorns OR mermaid
NET WT 4.2 OZ (119 g)
Cr_da2039905_ojtu-43018-01-mer_72016734 (Cr Da2039905 Ojtu 43018 01 Mer 72016734)
Cr_da2039904_ojtu-43018-01-uni_72016735 (Cr Da2039904 Ojtu 43018 01 Uni 72016735)
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