Label: ORAJEL KIDS MY WAY ANTICAVITY TOOTHPASTE- sodium fluoride gel, dentifrice
-
Contains inactivated NDC Code(s)
NDC Code(s): 10237-728-30 - Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 24, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- do not swallow
- supervise children as necessary until capable of using without supervision
children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years ask a dentist or doctor
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- QUESTIONS
- Principal Display Carton OJKFC-32370-01
-
INGREDIENTS AND APPEARANCE
ORAJEL KIDS MY WAY ANTICAVITY TOOTHPASTE
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-728 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) PEG-32 STEARATE (UNII: 33GX5WQC0M) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM LAURYL SULFATE (UNII: 368GB5141J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color blue Score Shape Size Flavor FRUIT (FRUIT BURST FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-728-30 1 in 1 CARTON 1 85 g in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/01/2011 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Accupac, Inc. 071609663 manufacture