ACT ANTICAVITY FLUORIDE RINSE KIDS SCOOBY DOO- sodium fluoride rinse

ACT Anticavity Fluoride Rinse Kids Scooby Doo by

Drug Labeling and Warnings

ACT Anticavity Fluoride Rinse Kids Scooby Doo by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 3. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active ingredient

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

Purpose

Anticavity  

Use

• aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

If more than used for rinsing is accidently swallowed, get medical help or contact 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
  
• pour out. Only the correct 10 milliliters dose will pour out
  
• 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

• contains FD&C yellow no.5 (tartrazine) as a color additive
  
• do not use if safety seal is broken or missing

Inactive ingredients

calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5 (309-023)

Principal Display Panel

ACT Kids
Anticavity Fluoride Rinse
Scooby-Doo! Kiwi Watermelon
Sodium Fluoride 0.05%
16.9 fl oz (500 mL)

INGREDIENTS AND APPEARANCE

ACT ANTICAVITY FLUORIDE RINSE KIDS SCOOBY DOO 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0934
Route of Administration	TOPICAL

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
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	KIWI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0934-0	500 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/01/2012

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 3		832973031	ANALYSIS(41167-0934) , LABEL(41167-0934) , MANUFACTURE(41167-0934) , PACK(41167-0934) , RECOVERY(41167-0934) , RELABEL(41167-0934) , REPACK(41167-0934)