DOLLAR GENERAL MAXIMUM STRENGTH- fluoride paste, dentifrice 
Dolgencorp LLC

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.

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5820042 DG Health Max Str Sensitive

Drug Facts

Active ingredients

Potassium nitrate 5%

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

Purpose

Antisensitivity

Anticavity

Uses

Warnings

Wnen using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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.

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush.

Inactive ingredients D&C yellow #10, FD& C blue #1, flavor, glycerin, hydrated silica, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, trisodium phosphate, water, xanthan gum

Store in a cool dry place. Keep tube capped when not in use.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

MADE IN U.S.A.

Carton R1

DOLLAR GENERAL  MAXIMUM STRENGTH
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-320
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINT (mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-320-391 in 1 CARTON01/20/201104/30/2025
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/20/201104/30/2025
Labeler - Dolgencorp LLC (068331990)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(55910-320)

Revised: 6/2022
Document Id: e1faf2b9-33ef-96bb-e053-2995a90a1faf
Set id: 1c7ad2a5-7d21-42e0-92e4-d08230424cfa
Version: 11
Effective Time: 20220621
 
Dolgencorp LLC