Hyvee Health Cool Blue Sugar Free (Eucalyptol, Menthol, Methyl Salicylate, Thymol) Mouthwash [Hyvee Inc] -

HYVEE HEALTH COOL BLUE SUGAR FREE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [HYVEE INC]
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Active ingredients

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Purpose

Antiplaque/Antigingivitis
Uses

to help reduce and prevent plaque and gingivitis.
Warnings

Do not use for children under 12 years of age.

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).
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), Alcohol, Poloxamer 407, Flavor, Benzoic Acid, Sodium Benzoate, Sodium Saccharin, Sucralose, Green 3 (CI 42053).
Label Copy

INGREDIENTS AND APPEARANCE

HYVEE HEALTH COOL BLUE SUGAR FREE
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 mg in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 124 (UNII: 1S66E28KXA)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42507-561-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	03/08/2016

Labeler - HYVEE INC (006925671)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(42507-561)

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