OTC Medication Information: 4x Medicated Toothache and Gum Cream

4X MEDICATED TOOTHACHE AND GUM CREAM- benzalkonium chloride, zinc chloride, benzocaine and menthol, unspecified form cream
CVS

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.

Benzalkonium chloride 0.13% . . . Oral antiseptic

Benzocaine 20% . . . Oral pain reliever

Menthol 0.26% . . . Oral pain reliever

Zinc chloride 0.15% . . . Oral astringent

Use

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

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 or 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 * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age

Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs

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

Directions

cut open tip of tube on score mark * adults and children 2 years of age and older: 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 dentist or doctor * children under 12 years of age should be supervised in teh use of this product * children under 2 years of age: do not use

Other information * do not use if tip is cut 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

ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

4X MEDICATED TOOTHACHE AND GUM CREAM benzocaine cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-631 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 g ZINC CHLORIDE (ZINC CATION) ZINC CATION 0.15 g in 100 g BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g in 100 g MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 0.26 g in 100 g

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (SACCHARIN) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SORBIC ACID AMMONIUM GLYCYRRHIZATE (GLYCYRRHIZIN)

Product Characteristics Color white (Cloudy White) Score Shape Size Flavor WINTERGREEN Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69842-631-19 1 TUBE in 1 CARTON contains a TUBE 1 9.4 g in 1 TUBE This package is contained within the CARTON (69842-631-19)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/05/2020

Labeler — CVS (062312574)

Registrant — Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Operations
Lornamead		080046418	manufacture (69842-631)

Revised: 01/2023 CVS