PM TOOTHACHE RELIEF- benzocaine paste 
Walgreens

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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For the temporary relief of pain due to toothaches. To help protect aganist infection of minor oral irritation.

ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-77, sodium saccharin, sorbic acid, titanium dioxide

Cut open tip of tube on score mark. Adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product. Children under 2 years of age: do not use.

Belzalkomium Chloride 0.13% Oral antiseptic

Benzocaine 20% Oral pain releiver

Methol 0.26% Oral pain releiver

Zinc chloride 0.15% Oral astringent

Keep out of reach of children. In case of overdose, get medical help or contact a POison Control Center right away.

Do not nuse if tube tip is cust prior to opening. This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously . This formula will stay in place for extended duration of relief. Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition tha tmust be treated promptly becuase it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy.

20% benzocaine to releive oral pain

Kills harmful bacteria

Astringent to help prevent infection

Cools gums and relieves irritation

Net Wt 0.25 oz (7g)

PDP

PM TOOTHACHE RELIEF 
benzocaine paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1623
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.26 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.242 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.26 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
CHAMOMILE (UNII: FGL3685T2X)  
SORBIC ACID (UNII: X045WJ989B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colorwhite (cloudy white to yellow) Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1623-091 in 1 BOX10/28/2022
17.1 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 finalpart35610/27/2022
Labeler - Walgreens (008965063)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(0363-1623) , pack(0363-1623)

Revised: 10/2022
 
Walgreens