AVON WHITENING ESSENTIALS ORIGINAL COOL MINT- sodium fluoride paste, dentifrice

AVON Whitening Essentials by

Drug Labeling and Warnings

AVON Whitening Essentials by is a Otc medication manufactured, distributed, or labeled by Tai Guk Pharm. Co., Ltd., Tai Guk Pharma. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredient

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Warnings

Keep out of reach of children.

Keep out of reach of children under 6 years of age. Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If an allergic reaction develops, discontinue to use immediately.

Directions

• Adults and children 6 years and older: Brush teeth thoroughly after each means or at least twice a day, or as directed by a dentist and physician. Do not swallow.
• Children between 6 and 12 years: To minimize swallowing, use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
• Children under 6 years: Ask a dentist or physician.

Inactive Ingredients

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose, xanthan gum, titanium dioxide, mica, charcoal powder, citrus limon(lemon) fruit extract, sodium chloride

QUESTIONS

1-800-FOR-AVON

www.avon.com

Principal Display Panel - 156 g Tube Carton

AVON

Whitening Essentials

FLUORIDE TOOTHPASTE

CAVITY PROTECTION

HELPS WHITEN TEETH - REMOVES SURFACE STAINS

ORIGINAL

COOL MINT

NET WT 5.5 oz (156 g)

INGREDIENTS AND APPEARANCE

AVON WHITENING ESSENTIALS  ORIGINAL COOL MINT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43136-901
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARRAGEENAN (UNII: 5C69YCD2YJ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
MICA (UNII: V8A1AW0880)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT (Cool)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43136-901-01	1 in 1 CARTON	07/31/2019
1		156 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	07/31/2019

Labeler - Tai Guk Pharm. Co., Ltd. (689060246)

Establishment
Name	Address	ID/FEI	Business Operations
Tai Guk Pharma. Co., Ltd.		689060246	manufacture(43136-901)