NATURAL WHITE RADIANT WHITE- fluoride paste, dentifrice

Natural White by

Drug Labeling and Warnings

Natural White by is a Otc medication manufactured, distributed, or labeled by Lornamead, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient

Sodium fluoride 0.243%

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.

DOSAGE & ADMINISTRATION

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

• Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing).
• Supervise children as necessary until capable of using without supervision.
• Children under 12 years of age: consult a dentist or a doctor.

INACTIVE INGREDIENT

Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, xanthan gum, carbomer, sodium saccharin, sodium hydroxide, mica, titanium dioxide, blue 1 lake, polyethylene

QUESTIONS

Questions or comments? CALL 1-877-777-2743

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Comments? Questions?

1-877-777-2473

customerservice@lornamead.com

Lornamead™

Manufactured by:

Lornamead, Inc.

Tonawanda, NY 14150

MADE IN USA

PRINCIPAL DISPLAY PANEL

RADIANT WHITE EXTREME

FLUORIDE ANTICAVITY WHITENING TOOTHPASTE

Whitens and removes surface stains from teeth

Enamel safe whitening formula

NET WT 2.7 OZ (76 g)

INGREDIENTS AND APPEARANCE

NATURAL WHITE  RADIANT WHITE
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62721-0473
Route of Administration	DENTAL

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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MICA (UNII: V8A1AW0880)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (light blue with sparkles)	Score
Shape		Size
Flavor	MINT (mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62721-0473-9	1 in 1 CARTON	01/01/2013
1		76 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	01/01/2013

Labeler - Lornamead (126440440)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(62721-0473)