KROGER KIDS ANTICAVITY FLUORIDE MIXED BERRY- sodium fluoride liquid

Kroger Kids Anticavity Fluoride by

Drug Labeling and Warnings

Kroger Kids Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by The Kroger Company, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Anticavity

Use

• Aids in the prevention of dental cavities.

Warnings

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.

Directions

• ​Adults and children 6 years of age and older:
• ​use twice daily after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• supervise children as necessary until capable of using without supervision
• ​Children under 6 years of age: consult a dentist or doctor

Other information

• Store at controlled room temperature 20°-25°C (68°-77°F)
• Cold weather may cloud this product.

Inactive ingredients

Water (Aqua), Xylitol, Glycerin, Zinc Chloride, Benzoic Acid, Flavor (Aroma), Methylparaben.

Questions or Comments?

1-800-632-6900

Label Copy

INGREDIENTS AND APPEARANCE

KROGER KIDS ANTICAVITY FLUORIDE  MIXED BERRY
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-563
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)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
ZINC CHLORIDE (UNII: 86Q357L16B)
BENZOIC ACID (UNII: 8SKN0B0MIM)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-563-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/20/2017

Labeler - The Kroger Company (006999528)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(30142-563)