DOLLAR SHAVE CLUB- sodium fluoride gel, dentifrice

Dollar Shave Club by

Drug Labeling and Warnings

Dollar Shave Club by is a Otc medication manufactured, distributed, or labeled by Dollar Shave Club, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sodium fluoride 0.24%
(0.15% 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 brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Twist off cap to remove foil seal. Do not use if safety seal is missing or broken.

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or physician.
• Do not swallow.
• Children under 6 years of age: Use a pea-sized amount and supervise until good brushing and rinsing habits are established (to minimize swallowing).
• Children under 2 years of age: Consult a dentist or a physician.

Inactive Ingredients

Sorbitol, Hydrated Silica, Glycerin, Xylitol, Purified Water, Sodium Lauryl Sulfate, Flavor, Xanthan Gum, Stevia Rebaudiana Leaf Extract, Blue 1 and Yellow 10.

PRINCIPAL DISPLAY PANEL - 142 g Tube Label

SUPERBA

PEPPERMINT KICK

FLUORIDE GEL TOOTHPASTE

NET WT 5.0 OZ (142g)

INGREDIENTS AND APPEARANCE

DOLLAR SHAVE CLUB 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69522-1112
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated silica (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Glycerin (UNII: PDC6A3C0OX)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium lauryl sulfate (UNII: 368GB5141J)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT (Peppermint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69522-1112-2	90 g in 1 TUBE; Type 0: Not a Combination Product	06/28/2018
2	NDC: 69522-1112-1	28 g in 1 TUBE; Type 0: Not a Combination Product	06/28/2018
3	NDC: 69522-1112-3	142 g in 1 TUBE; Type 0: Not a Combination Product	06/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/28/2018

Labeler - Dollar Shave Club (004164494)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	MANUFACTURE(69522-1112)