ASTONEA MAXIMUM STRENGTH ORAL PAIN RELIEF- benzocaine 20%, benzalkonium chloride 1% gel

ASTONEA Maximum Strength Oral Pain Relief by

Drug Labeling and Warnings

ASTONEA Maximum Strength Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Antiseptic

Use

• for the temporary relief of pain due to toothaches
• to help protect against infection in minor oral irritation

Warnings



Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because 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

Allergy alert:do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

DO NOT USE

Do not use

• more than directed
• for more than 7 days unless directed by a physician or healthcare provider

ASK DOCTOR

Stop use and ask a physician if

• swelling, rash or fever develops
• irritation, pain or redness persists or worsens
• symptoms do not improve in 7 days

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN:

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away (1-800-222-1222)

DOSAGE & ADMINISTRATION

Directions

• Adults and children 2 years of age and over -Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
• Children under 12 years of age -Should be supervised in the use of this product
• Children under 2 years of age- Ask a physician or healthcare provider

Other information

• this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
• do not use continuously
• avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
• do not use if tube seal under cap is broken
• store at 20-25C (68-77F)

Inactive ingredients

aloe vera leaf, butylated hydroxytoluene, carbomer, cetyl alcohol, cholecalciferol, edetate disodium anhydrous, ethylhexylglycerin & phenoxyethanol, glycerol monostearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, light mineral oil, PEG 100
stearate, PEG 4000, propylene glycol, sodium benzoate, sodium hydroxide, sodium laureth sulfate, sodium metabisulfite, sodium sulfite, vitamin A palmitate, vitamin E, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASTONEA MAXIMUM STRENGTH ORAL PAIN RELIEF 
benzocaine 20%, benzalkonium chloride 1% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-201-01	1 in 1 CARTON	02/01/2022
1		9.35 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	M013	02/01/2022

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)