Up & Up 004.002/004ae

Up & Up 004.002/004ae
SPL v19
SPL
SPL Set ID abfc1973-60ab-44e5-8147-33739d8bd7a3
Route
ORAL
Published
Effective Date 2025-03-19
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 2011-08-26

Description

Saftey sealed with printed neckband for your protection

Purpose

Anticavity 


Medication Information

Purpose

Anticavity 

Description

Saftey sealed with printed neckband for your protection

Use

aids in the prevention of dental cavities

Warnings

for this product

Directions

Adults and children 6 years of age and older:

  • use once a day after brushing your teeth with toothpaste
  • vigorously swish 10 mililiters 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 Chattem, Inc., distributor of ACT ®Bubblegum Blowout ® Anticavity Kids Fluoride Rinse.

Adverse Reaction

Distributed by Target Corporation Mpls., MN 55403

Made in the U.S.A. with U.S. and foreign components.

TM & ©2024 Target Brands, Inc.

Guest Services 1-800-910-6874

049 08 0009 R01 C-002445-01-024-0149

Pat. D604,628

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

Compare to active ingredient in ACT ®Bubblegum Blowout ®Anticavity Kids Fluoride Rinse*

Kids' Anticavity Fluoride Rinse

  • Helps prevent cavities
  • Helps strengthen teeth
  • IMPORTANT: read directions for proper use

Bubblegum Flavor

Alcohol free

up & up ™

ADA Accepted

American Dental Association

Helps prevent cavities

16.9 FL OZ (1.05 PT) 500 mL

Tamper Evident Statement

Saftey sealed with printed neckband for your protection

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 years of age and older:

  • use once a day after brushing your teeth with toothpaste
  • vigorously swish 10 mililiters 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 Chattem, Inc., distributor of ACT ®Bubblegum Blowout ® Anticavity Kids Fluoride Rinse.

Adverse Reaction (Adverse reaction)

Distributed by Target Corporation Mpls., MN 55403

Made in the U.S.A. with U.S. and foreign components.

TM & ©2024 Target Brands, Inc.

Guest Services 1-800-910-6874

049 08 0009 R01 C-002445-01-024-0149

Pat. D604,628

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)

Compare to active ingredient in ACT ®Bubblegum Blowout ®Anticavity Kids Fluoride Rinse*

Kids' Anticavity Fluoride Rinse

  • Helps prevent cavities
  • Helps strengthen teeth
  • IMPORTANT: read directions for proper use

Bubblegum Flavor

Alcohol free

up & up ™

ADA Accepted

American Dental Association

Helps prevent cavities

16.9 FL OZ (1.05 PT) 500 mL

Tamper Evident Statement

Saftey 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, seek professional assistance or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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