ACT KIDS PURE PROTECT ANTICAVITY- SIMPLY STRAWBERRY- sodium fluoride rinse

ACT Kids Pure Protect Anticavity- Simply Strawberry by

Drug Labeling and Warnings

ACT Kids Pure Protect Anticavity- Simply Strawberry by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACT Kids Pure Protect Anticavity Mouthwash

Drug Facts

Active ingredients

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

Purpose

Anticavity

Uses

■ aids in the prevention of dental cavities

Warnings

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 older:

• use once a day after brushing your teeth with a toothpaste
  
• remove cap
  
• hold bottle upright and squeeze. Fill to FILL LINE (10mL)
  
• 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 years of age: consult a dentist or doctor

Other information

Do not use if safety seal is broken or missing.

Inactive ingredients

cetylpyridinium chloride, dipotassium glycyrrhizinate, disodium phosphate, flavor, glycerin, poloxamer 407, polysorbate 20, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, stevia rebaudiana leaf/stem extract, water, xylitol

PRINCIPAL DISPLAY PANEL

ACT
Kids
Anticavity
Fluoride Rinse
Simply
Strawberry
16.9 fl oz (500 mL)

INGREDIENTS AND APPEARANCE

ACT KIDS PURE PROTECT ANTICAVITY- SIMPLY STRAWBERRY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0915
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SORBITOL (UNII: 506T60A25R)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0915-0	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/04/2024

Labeler - Chattem, Inc. (003336013)