Family Wellness 004.002/004ae

Family Wellness 004.002/004ae
SPL v11
SPL
SPL Set ID 32a92add-c9db-4733-8e35-613825fdf081
Route
ORAL
Published
Effective Date 2025-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Benzyl Alcohol Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Edetate Disodium Sodium Phosphate, Dibasic, Anhydrous Poloxamer 407 Polysorbate 80 Propylene Glycol D&c Red No. 33 Sodium Benzoate Sodium Phosphate Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-08-02

Description

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)        

Purpose

Anticavity 


Medication Information

Purpose

Anticavity 

Description

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)        

Use

aids in the prevention of dental cavities

Warnings

for this product

Directions

Adults and children 6 year of age and older: 

  • use once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters 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 year of age: consult a dentist or doctor

Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ® Bubblegum Blow Out ® Anticavity Kids Fluoride Rinse.

Adverse Reaction

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PKWY

CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?

Return within 30 days to the store of purchase for a refund (with receipt) or exchange.

MADE IN THE US WITH US AND FOREIGN COMPONENTS

Active Ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)        

Other Information
  • store at room temperature
Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel

IMPORTANT: read directions for proper use.

Sealed with printed neckband for your protection.

Do not use if band around cap is broken or missing.

FAMILY WELLNESS™

Compare to ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse*

Children's ANTICAVITY FLUORIDE RINSE

  • Strong cavity protection
  • Alcohol free
  • Helps strengthen teeth
  • Helps prevent cavities

BUBBLEGUM FLAVOR

18 FL OZ (1.12 PT) 532 mL

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity 

Warnings

for this product

Directions

Adults and children 6 year of age and older: 

  • use once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters 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 year of age: consult a dentist or doctor

Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ® Bubblegum Blow Out ® Anticavity Kids Fluoride Rinse.

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PKWY

CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?

Return within 30 days to the store of purchase for a refund (with receipt) or exchange.

MADE IN THE US WITH US AND FOREIGN COMPONENTS

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)        

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel (Principal display panel)

IMPORTANT: read directions for proper use.

Sealed with printed neckband for your protection.

Do not use if band around cap is broken or missing.

FAMILY WELLNESS™

Compare to ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse*

Children's ANTICAVITY FLUORIDE RINSE

  • Strong cavity protection
  • Alcohol free
  • Helps strengthen teeth
  • Helps prevent cavities

BUBBLEGUM FLAVOR

18 FL OZ (1.12 PT) 532 mL

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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