PEPPERMINT TWIST- fluoride paste, dentifrice

Peppermint Twist by

Drug Labeling and Warnings

Peppermint Twist by is a Otc medication manufactured, distributed, or labeled by Caldwell Health LLC, GORAN PHARMA PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Sodium fluoride (0.24%) (0.15% w/v fluoride ion)

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use

Aids in the prevention of dental cavities.

WARNINGS

Warnings

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if the safety seal is missing or broken.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 2 years of age and older: Brush teeh thoroughly, preferably after each meal or at least twice or as directed by a dentist or physician.
• Children 2 to 6 years: Use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).
• Children under 2 years: Ask a dentist or physician.

STORAGE AND HANDLING

Other information

Store standing up with cap tightly closed.

INACTIVE INGREDIENT

Inactive ingredients Glycerin, hydrated silica, sorbitol, water, xylitol, Aloe barbadensis leaf juice, cocamidopropyl betaine, sodium cocoylglycinate, cellulose gum, titanium dioxide, Echinacea angustifolia extract, natural flavors (contains Cinnamomum cassie leaf oil), Hydrastis canadensis (goldenseal) extract, Calendula officinalis extract, xanthan gum, citric acid, zinc citrate, Citrus grandis (grapefruit) seed extract.

QUESTIONS

Questions? Call 1-888-317-4402, weekdays 9 to 5 ET.

SPL UNCLASSIFIED SECTION

Manufactured for Revive Personal Products Company,

Madison, NJ 07940

© 2018 Revive Personal Products Company.
Made in USA. Vegan. Not tested on animals.

PRINCIPAL DISPLAY PANEL

NO SLS!

THE NATURAL DENTIST

ALL IN ONE

FLUORIDE TOOTHPASTE

with Purified Aloe Vera

• Prevents Cavities
• Whitens Teeth
• Strengthens Tooth Enamel
• Fights Tartar
• Freshens Breath

PEPPERMINT TWIST

NET WT. 5.0 OZ (141g)

INGREDIENTS AND APPEARANCE

PEPPERMINT TWIST 
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34362-0237
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
GOLDENSEAL (UNII: ZW3Z11D0JV)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ZINC CITRATE (UNII: K72I3DEX9B)
CITRUS MAXIMA SEED (UNII: 083X55C543)

Product Characteristics
Color	white (Off White)	Score
Shape		Size
Flavor	PEPPERMINT (Peppermint Twist)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34362-0237-2	1 in 1 BOX	04/11/2018
1		142 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/11/2018

Labeler - Caldwell Health LLC (828558713)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(34362-0237)

Establishment
Name	Address	ID/FEI	Business Operations
GORAN PHARMA PRIVATE LIMITED		862174088	manufacture(34362-0237)