PM TOOTHACHE RELIEF- benzocaine paste

PM Toothache Relief by

Drug Labeling and Warnings

PM Toothache Relief by is a Otc medication manufactured, distributed, or labeled by Walgreens, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

INDICATIONS & USAGE

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.

ACTIVE INGREDIENT

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

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

PURPOSE

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.

WARNINGS

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.

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

PM TOOTHACHE RELIEF 
benzocaine paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1623
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.26 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.15 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (cloudy white to yellow)	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1623-09	1 in 1 BOX	10/28/2022
1		7.1 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 Drug	M017	10/27/2022

Labeler - Walgreens (008965063)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(0363-1623) , pack(0363-1623)