Up & Up 213.002/213ae Rev 2

Up & Up 213.002/213ae Rev 2
SPL v17
SPL
SPL Set ID 3daf3cc3-585a-4bb2-9b56-7117d220ed38
Route
ORAL
Published
Effective Date 2025-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Sorbitol Menthol Methyl Salicylate Cetylpyridinium Chloride Saccharin Sodium Poloxamer 407 Polysorbate 20 Propylene Glycol Sodium Phosphate Sodium Phosphate, Dibasic, Anhydrous Edetate Calcium Disodium Anhydrous Edetate Disodium Anhydrous Sodium Benzoate Potassium Sorbate Benzyl Alcohol Fd&c Green No. 3 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-08-17

Description

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

Purpose

Anticavity rinse


Medication Information

Purpose

Anticavity rinse

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 years of age and older: use once a day after brushing your teeth with toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute then spit it 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 .

Adverse Reaction

Dist. by Target Corp., Mpls, MN 55403

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

©2018 Target Brands, Inc. Shop Target.com

Guest Services 1-800-910-6874

Empty and Replace Cap

PLASTIC BOTTLE

how2recycle.info

Active Ingredient

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

Other Information
  • store at room temperature
Inactive Ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Principal Display Panel

SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADA Accepted

America Dental Association

Helps prevent cavities

anticavity

fluoride

mouthrinse

Compare to Act ®Anticavity Fluoride Rinse*

helps prevent cavities

helps strengthen teeth

freshens breath

up & up ™

MINT FLAVOR

IMPORTANT: read directions for proper use

18 FL OZ (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 rinse

Warnings

for this product

Directions
  • Adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute then spit it 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 .

Adverse Reaction (ADVERSE REACTION)

Dist. by Target Corp., Mpls, MN 55403

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

©2018 Target Brands, Inc. Shop Target.com

Guest Services 1-800-910-6874

Empty and Replace Cap

PLASTIC BOTTLE

how2recycle.info

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)

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Principal Display Panel (Principal display panel)

SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADA Accepted

America Dental Association

Helps prevent cavities

anticavity

fluoride

mouthrinse

Compare to Act ®Anticavity Fluoride Rinse*

helps prevent cavities

helps strengthen teeth

freshens breath

up & up ™

MINT FLAVOR

IMPORTANT: read directions for proper use

18 FL OZ (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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