Dg Health 163.005/163af-ag

Dg Health 163.005/163af-ag
SPL v19
SPL
SPL Set ID 64f3d92d-f58c-4bc2-8819-f91492221ddb
Route
ORAL
Published
Effective Date 2025-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Eucalyptol Methyl Salicylate Menthol, Unspecified Form Phosphoric Acid Saccharin Sodium Thymol Sodium Phosphate, Dibasic, Anhydrous Sucralose Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2006-05-13 Until 2025-08-22

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Use

aids in the prevention of dental cavities

Warnings

for this product

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
Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ®Total Care Anticavity Mouthwash.

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

DSP-TN-21091

DSP-MO-20087

Active Ingredient

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

Other Information
  • store at controlled room temperature 20⁰- 25⁰C (68⁰- 77⁰F)

  • cold weather may temporarily cloud this product

Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Panel Display

DG ®health

Compare to Listerine ®Total Care Anticavity Mouthwash*

Anticavity

Fluoride

Rinse

Sodium Fluoride and Acidulated Phosphate Topical Solution

Eucalyptus Mint

Multiple Benefits in one

  • Helps prevent cavities
  • Helps strengthen teeth
  • Restores enamel
  • Kills bad breath germs

IMPORTANT: read directions for proper use.

250 mL (8.5 FL OZ)

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.

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.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

for this product

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
Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ®Total Care Anticavity Mouthwash.

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

DSP-TN-21091

DSP-MO-20087

Active Ingredient (Active ingredient)

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

Other Information (Other information)
  • store at controlled room temperature 20⁰- 25⁰C (68⁰- 77⁰F)

  • cold weather may temporarily cloud this product

Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Panel Display

DG ®health

Compare to Listerine ®Total Care Anticavity Mouthwash*

Anticavity

Fluoride

Rinse

Sodium Fluoride and Acidulated Phosphate Topical Solution

Eucalyptus Mint

Multiple Benefits in one

  • Helps prevent cavities
  • Helps strengthen teeth
  • Restores enamel
  • Kills bad breath germs

IMPORTANT: read directions for proper use.

250 mL (8.5 FL OZ)

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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