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NDC 37808-0576-86 Alcohol Free Refreshing Mint 10.41 mg/mL Details

Alcohol Free Refreshing Mint 10.41 mg/mL

Alcohol Free Refreshing Mint is a ORAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by HEB. 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: 37808-0576-86
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	37808-0576
Product ID	37808-576_5535461d-443f-4b39-851b-82e32130ba17
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Alcohol Free Refreshing Mint
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	ORAL
Active Ingredient Strength	10.41
Active Ingredient Units	mg/mL
Substance Name	SODIUM FLUORIDE
Labeler Name	HEB
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2024-12-31

Package

Package Images

NDC 37808-0576-86 (37808057686)

Pricing Information	N/A
NDC Package Code	37808-576-86
Billing NDC	37808057686
Package	1000 mL in 1 BOTTLE, PLASTIC (37808-576-86)
Marketing Start Date	2015-04-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cedf7c08-7412-4733-9b67-225b331cec8c Details

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

claims

H-E-B

Refreshing Mint

ALCOHOL

FREE

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

For this product

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children 6 years of age and oler:

use twice a day after brushing your teeth with 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
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessare until capable of using without supervision
children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

Questions

Call 1-888-593-0593

Claims

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

Adverse Reactions

MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204

disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Anticavity Fluoride Mouthwash

principal display panel

Compare to Crest

Pro-Health Anticavity

Fluoride MouthWash

H-E-B

Refreshing Mint

ALCOHOL

FREE

ANTICAVITY MOUTH RINSE

WITH FLUORIDE

Helps prevent cavities
Helps fight germs that cause bad breath
Freshens breath with no alcohol burn

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 QT) 1L

INGREDIENTS AND APPEARANCE

ALCOHOL FREE REFRESHING MINT

sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-576
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	10.41 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37808-576-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	04/27/2015

Labeler - HEB (007924756)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(37808-576)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(37808-576)

Revised: 4/2022

Document Id: 5535461d-443f-4b39-851b-82e32130ba17

Set id: cedf7c08-7412-4733-9b67-225b331cec8c

Version: 10

Effective Time: 20220420