HYVEE COMPLETE CARE FRESH MINT- sodium fluoride liquid

HYVEE by

Drug Labeling and Warnings

HYVEE by is a Otc medication manufactured, distributed, or labeled by HYVEE INC., APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)

Purpose

Antigingivitis/Antiplaque

Uses

to help reduce and prevent

• plaque
• gingivitis

Warnings

Do not use in children under 12 years of age

Keep out of reach of children

If more than used for rinsing is accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions

• Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
• Do not swallow

Other information

• Store at room temperature
• Cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

Water (Aqua), Sorbitol, Alcohol (21.6%), Poloxamer 407, Sodium Lauryl Sulfate, Eucalyptol, Flavor, Methyl Salicylate, Thymol, Phosphoric Acid, Sucralose, Menthol, Disodium Phosphate, Red 40 (CI 16035), Blue 1 (CI 42090).

Questions or comments?

1-800-289-8343

Label Copy

INGREDIENTS AND APPEARANCE

HYVEE  COMPLETE CARE FRESH MINT
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-552
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-552-33	1000 mL in 1 BOTTLE, PLASTIC; 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	09/12/2013

Labeler - HYVEE INC. (006925671)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(42507-552)