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NDC 81175-0000-02 Oral7 Dry Mouth Moisturizing 7.6 mg/mL Details
Oral7 Dry Mouth Moisturizing 7.6 mg/mL
Oral7 Dry Mouth Moisturizing is a DENTAL PASTE, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by Oral7 USA Operations Inc. The primary component is SODIUM MONOFLUOROPHOSPHATE.
Product Information
| NDC | 81175-0000 |
|---|---|
| Product ID | 81175-000_c4bd3ffa-9a36-894e-e053-2995a90a2c95 |
| 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 | Oral7 Dry Mouth Moisturizing |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | SODIUM MONOFLUOROPHOSPHATE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PASTE, DENTIFRICE |
| Route | DENTAL |
| Active Ingredient Strength | 7.6 |
| Active Ingredient Units | mg/mL |
| Substance Name | SODIUM MONOFLUOROPHOSPHATE |
| Labeler Name | Oral7 USA Operations Inc |
| 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 81175-0000-02 (81175000002)
| NDC Package Code | 81175-000-02 |
|---|---|
| Billing NDC | 81175000002 |
| Package | 75 mL in 1 TUBE (81175-000-02) |
| Marketing Start Date | 2019-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c4bd3ffa-9a35-894e-e053-2995a90a2c95 Details
Warnings
Directions
Adults and Children 2 years of age and older
- Use 2-3 times a day, 7 days a week.
- Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist.
- Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.
Inactive ingredients
DICALCIUM PHOSPHATE, HYDROGENATED STARCH HYDROLYSATE, GLYCERIN, AQUA, SILICA, DEXTROSE MONOHYDRATE, HYDRATED SILICA, ISOCETETH-20, XYLITOL, SODIUM MONOFLUOROPHOSPHATE, XANTHAN GUM, MENTHA PIPERITA (PEPPERMINT OIL), SODIUM BENZOATE, LACTOPEROXIDASE, POTASSIUM THIOCYANATE, LACTOFERRIN, LYSOZYME, GLUCOSE OXIDASE, LIMONENE, CALCIUM LACTATE
Questions
or Comments? Tel.: +1 833-672-5787 weekdays or Email : [email protected] / oral7us.com
Always follow the label
SPL UNCLASSIFIED SECTION
ORAL7
REAL DRY MOUTH RELIEF
TOOTHPASTE
Fluoride & Calcium
2.5 fl oz 75 ml (105g)
SUGAR FREE
Naturally Sweetened with Xylitol
Made in the EU
Oral7 International Pty. Ltd.
Suite 2, 15 Delawney Street
Balcatta, WA 6021 AUSTRALIA
USA & Canada
Oral7 U.S. (Op) [email protected]
www.oral7us.com
INGREDIENTS AND APPEARANCE
| ORAL7 DRY MOUTH MOISTURIZING
sodium monofluorophosphate paste, dentifrice |
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| Labeler - Oral7 USA Operations Inc (117789267) |