Indications and uses
Aids in the prevention of dental cavities
SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF
- Manufacturer
- Sunstar Americas, Inc.
- Effective date
- 2021-01-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:57:32
Label at a glance#
ProductSUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF
Active ingredientSODIUM FLUORIDE
Label structure9 sections
Dosage and administration
Adults and children 2 years & older; brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Sodium fluoride 0.24% w/w
Purpose
Anticavity
Uses
Aids in the prevention of dental cavities
Warning:
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
| Adults and children 2 years & older; brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor |
| 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:
Sorbitol, purified water, hydrated silica, isomalt, lauryl glucoside, cocamidopropyl betaine, PEG-8, xanthan gum, xylitol, panthenol, flavor, sodium benzoate, sucralose, tocopheryl acetate, aloe barbadenisis leaf juice powder, cetylpyridinium chloride, bisabolol, FD&C blue #1, zingiber officinale (ginger) root extract.
Questions:
1-888-777-3101
SPL UNCLASSIFIED SECTION
anti-cavity toothpaste
gentle formula WITH ALOE
G•U•M® Hydral Toothpaste is a gentle fluoride toothpaste with a combination of high-value, natural ingredients such as Aloe Vera, Chamomile (Bisabolol) and Ginger Root extract that provide moisturization and are non-irritating.
Discover other moisturizing products in the G•U•M® Hydral Dry Mouth Relief range:
Oral Rinse - ideal for your daily routine
Moisturizing Spray – ideal for on-the-go relief
Oral Gel - ideal for night time or under dentures.
• Low Irritation Formula
• Alcohol Free
Made in the USA
Manufactured by:
Sunstar Americas, Inc., 301 East Central Road, Schaumburg, IL 60195
GUMbrand.com
Packaging
Products#
Every source-derived product name is available through these pages.
- SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF
- Sodium fluoride
- FLUORIDE ION
- SORBITOL
- WATER
- HYDRATED SILICA
- ISOMALT
- LAURYL GLUCOSIDE
- COCAMIDOPROPYL BETAINE
- POLYETHYLENE GLYCOL 400
- XANTHAN GUM
- XYLITOL
- PANTHENOL
- SODIUM BENZOATE
- SUCRALOSE
- .ALPHA.-TOCOPHEROL ACETATE
- ALOE VERA LEAF
- CETYLPYRIDINIUM CHLORIDE
- LEVOMENOL
- FD&C BLUE NO. 1
- GINGER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52376-045 | 52376-045-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ecada87e-96f3-7e50-e053-2a95a90a8ae6 | ab1731ea-d78b-48b7-96a2-1ff4543c7f02 | 2022-11-04 | Warnings | ab1731ea-d78b-48b7-96a2-1ff4543c7f02 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.