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NDC 30142-0563-16 Kroger Kids Anticavity Fluoride 0.2 mg/mL Details

Kroger Kids Anticavity Fluoride 0.2 mg/mL

Kroger Kids Anticavity Fluoride is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Kroger Company. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 30142-0563-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	30142-0563
Product ID	30142-563_b37f34ae-da59-455f-b879-83bd0f1adb63
Associated GPIs
GCN Sequence Number	012074
GCN Sequence Number Description	guaifenesin/dextromethorphan TAB ER 12H 600MG-30MG ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	53550
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Kroger Kids Anticavity Fluoride
Proprietary Name Suffix	Mixed Berry
Non-Proprietary Name	Sodium Fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	0.2
Active Ingredient Units	mg/mL
Substance Name	SODIUM FLUORIDE
Labeler Name	The Kroger Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2022-12-31

Package

Package Images

NDC 30142-0563-16 (30142056316)

Pricing Information	N/A
NDC Package Code	30142-563-16
Billing NDC	30142056316
Package	500 mL in 1 BOTTLE, PLASTIC (30142-563-16)
Marketing Start Date	2017-01-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b409c574-67d5-445c-a015-25cf543cb6e4 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
ZINC CHLORIDE (UNII: 86Q357L16B)
BENZOIC ACID (UNII: 8SKN0B0MIM)
METHYLPARABEN (UNII: A2I8C7HI9T)

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

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

Labeler - The Kroger Company (006999528)

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

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

Revised: 1/2017

Document Id: b37f34ae-da59-455f-b879-83bd0f1adb63

Set id: b409c574-67d5-445c-a015-25cf543cb6e4

Version: 1

Effective Time: 20170123