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NDC 48878-4020-03 Just For Kids 0.969 mg/g Details
Just For Kids 0.969 mg/g
Just For Kids is a ORAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by 3M ESPE Dental Products. The primary component is STANNOUS FLUORIDE.
Product Information
| NDC | 48878-4020 |
|---|---|
| Product ID | 48878-4020_3f618a29-cbbb-4b39-930b-a742c89ce40c |
| Associated GPIs | 88402030004010 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Just For Kids |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | stannous fluoride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | ORAL |
| Active Ingredient Strength | 0.969 |
| Active Ingredient Units | mg/g |
| Substance Name | STANNOUS FLUORIDE |
| Labeler Name | 3M ESPE Dental Products |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 48878-4020-03 (48878402003)
| NDC Package Code | 48878-4020-3 |
|---|---|
| Billing NDC | 48878402003 |
| Package | 1 TUBE in 1 BOX (48878-4020-3) / 121.9 g in 1 TUBE |
| Marketing Start Date | 1997-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0f1afc36-f699-4072-b90b-c9f5be989a49 Details
Warnings
- This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
- Keep out of reach of children. If more than used for brushing is accidentally swallowed, gel medical help or contact a Poison Control Center right away.
- This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Directions
- Adults and children 6 years of age and older: Use a pea-sized (.25g) dose once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: Consult a dentist or doctor.
Other information
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| JUST FOR KIDS
stannous fluoride gel |
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| JUST FOR KIDS
stannous fluoride gel |
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| Labeler - 3M ESPE Dental Products (801390852) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Dental Technologies, Inc. | 148312838 | manufacture(48878-4020, 48878-4070) | |
Revised: 6/2019
Document Id: 3f618a29-cbbb-4b39-930b-a742c89ce40c
Set id: 0f1afc36-f699-4072-b90b-c9f5be989a49
Version: 4
Effective Time: 20190612