SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF- sodium fluoride paste, dentifrice

SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF by

Drug Labeling and Warnings

SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF by is a Otc medication manufactured, distributed, or labeled by Sunstar Americas, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Sodium fluoride 0.24% w/w

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Warning:

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

GUM® 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 GUM® 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

INGREDIENTS AND APPEARANCE

SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52376-045
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ISOMALT (UNII: S870P55O2W)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
LEVOMENOL (UNII: 24WE03BX2T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52376-045-11	1 in 1 CARTON	11/19/2019
1		119 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/19/2019

Labeler - Sunstar Americas, Inc. (025066358)

Establishment
Name	Address	ID/FEI	Business Operations
Sunstar Americas, Inc.		025066358	manufacture(52376-045)