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NDC 37000-0006-15 Crest Pro-Health For Me 0.1 mg/mL Details
Crest Pro-Health For Me 0.1 mg/mL
Crest Pro-Health For Me is a ORAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is SODIUM FLUORIDE.
MedlinePlus Drug Summary
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 37000-0006-15Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 37000-0006 |
|---|---|
| Product ID | 37000-006_41fc6c25-996b-6e44-e054-00144ff88e88 |
| Associated GPIs | |
| 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 | Crest Pro-Health For Me |
| Proprietary Name Suffix | Anticavity Fluoride |
| Non-Proprietary Name | Sodium Fluoride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | RINSE |
| Route | ORAL |
| Active Ingredient Strength | 0.1 |
| Active Ingredient Units | mg/mL |
| Substance Name | SODIUM FLUORIDE |
| Labeler Name | The Procter & Gamble Manufacturing Company |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 37000-0006-15 (37000000615)
| NDC Package Code | 37000-006-15 |
|---|---|
| Billing NDC | 37000000615 |
| Package | 500 mL in 1 BOTTLE, PLASTIC (37000-006-15) |
| Marketing Start Date | 2015-01-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL eeea70d7-bd29-49ae-8363-22eee6fa2f80 Details
Warnings
Directions
- Adults and children 6 years & older: Use twice a day after brushing your teeth with a toothpaste.
- To dispense 10 mL dose: Remove cap and squeeze the front and back of the bottle (not the sides) to fill the reservoir. Allow excess liquid to drain back into the bottle. Pour out the dose.
- Vigorously swish the 10 mL of rinse between your teeth for 1 minute and then spit out.
- Do not swallow the rinse.
- Do not eat or drink for 30 minutes after rinsing.
- Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: Consult a dentist or doctor.
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
INGREDIENTS AND APPEARANCE
| CREST PRO-HEALTH FOR ME
ANTICAVITY FLUORIDE
sodium fluoride rinse |
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| Labeler - The Procter & Gamble Manufacturing Company (004238200) |
Revised: 11/2016
Document Id: 41fc6c25-996b-6e44-e054-00144ff88e88
Set id: eeea70d7-bd29-49ae-8363-22eee6fa2f80
Version: 4
Effective Time: 20161123