AVON WHITENING ESSENTIALS ORIGINAL COOL MINT- sodium fluoride paste, dentifrice 
Tai Guk Pharm. Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

AVON Whitening Essentials Original Cool Mint

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 olderBrush 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 yearsTo minimize swallowing, use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
Children under 6 yearsAsk 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

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)

COOLMINT

AVON WHITENING ESSENTIALS  ORIGINAL COOL MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43136-901
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorMINT (Cool) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43136-901-011 in 1 CARTON07/31/2019
1156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/31/2019
Labeler - Tai Guk Pharm. Co., Ltd. (689060246)
Establishment
NameAddressID/FEIBusiness Operations
Tai Guk Pharma. Co., Ltd.689060246manufacture(43136-901)

Revised: 7/2019
Document Id: 8e5dce76-df8c-5878-e053-2a95a90a3f04
Set id: 8e5de76b-535a-9c95-e053-2995a90afcab
Version: 1
Effective Time: 20190719
 
Tai Guk Pharm. Co., Ltd.