Hello Wild Strawberry by Accupac LLC

Hello Wild Strawberry by

Drug Labeling and Warnings

Hello Wild Strawberry by is a Otc medication manufactured, distributed, or labeled by Accupac LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HELLO WILD STRAWBERRY- sodium fluoride mouthwash 
Accupac LLC

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Hello Wild Strawberry

Drug Facts

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 under 6 years of age.

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
-vigorously swish 10 mL (2 teaspoonfuls) 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

-Store at room temperature

-Do not use if printed band around cap is broken or missing

Inactive ingredients

purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, phosphoric acid, potassium citrate.

Questions?

1-855-444-3556
Dist. by Hello Products
LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

naturally
friendly
hello
ADA
Accepted
American
Dental
Association ®
kids fluoride rinse
anticavity + no alcohol
wild strawberry
natural flavor
rinses away stuff brushing misses.
prevents cavities.
tastes awesome.
16 FL OZ (1 PT) 473 mL
44949

HELLO WILD STRAWBERRY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0685
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PHOSPHORIC ACID (UNII: E4GA8884NN)
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: 44038-0685-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/01/2023

Labeler - Accupac LLC (071609663)

Registrant - Accupac LLC (061595175)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(44038-0685)

Revised: 10/2024

Document Id: 23f7c9a1-40b9-76ff-e063-6394a90a7d28

34390-5

Set id: 23f7c9a1-40b8-76ff-e063-6394a90a7d28

Version: 1

Effective Time: 20241008