Dollar Shave Club

Dollar Shave Club
SPL v1
SPL
SPL Set ID af824de9-172e-48b6-8cb0-f78a08bf21a6
Route
DENTAL
Published
Effective Date 2018-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Sorbitol Hydrated Silica Water Xylitol Glycerin Xanthan Gum Sodium Lauryl Sulfate Stevia Rebaudiuna Leaf Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-06-28

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Aids in the prevention of dental cavities.

Section 42229-5

Drug Facts

Section 50565-1

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.
Active Ingredient

Sodium fluoride 0.24%

(0.15% w/v fluoride ion)

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)


Structured Label Content

Use

Aids in the prevention of dental cavities.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Anticavity

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.
Active Ingredient

Sodium fluoride 0.24%

(0.15% w/v fluoride ion)

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 (PRINCIPAL DISPLAY PANEL - 142 g Tube Label)

SUPERBA

PEPPERMINT KICK

FLUORIDE GEL TOOTHPASTE

NET WT 5.0 OZ (142g)


Advanced Ingredient Data


Raw Label Data

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