OTC Medication Information: 4X Medicated Severe Toothache and Gum Gel

4X MEDICATED SEVERE TOOTHACHE AND GUM GEL- benzalkonium chloride, zinc chloride, menthol and benzocaine gel
Rite Aid

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.

Active Ingredients Purpose

Benzalkonium Chloride 0.13% …. Oral Antiseptic

Benzocaine 20% ……………………. Oral Pain Reliever

Menthol 0.5% ………………………… Oral Pain Reliever

Zinc Chloride 0.15% ……………….. Oral Astringent

Use

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

Warnings

Methemoglobinemia warning: use of this product ay cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in teh 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 lightneadedness * 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 to score mark * adults and children 2 years of age and older: apply a small amount of product to teh 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 the use of this product * children under 2 years of age: do not use

Other Information

Other information * do not use if tip is cut prior to ening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use ontinuously * this formula will stay in place for extended duration of reilef * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid

Carton R2
(click image for full-size original)

4X MEDICATED SEVERE TOOTHACHE AND GUM GEL
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0615
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
MENTHOL (MENTHOL) MENTHOL 0.5 g in 100 g
BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
SORBIC ACID
SACCHARIN SODIUM (SACCHARIN)
FD&C BLUE NO. 1
METHYL SALICYLATE
AMMONIUM GLYCYRRHIZATE (GLYCYRRHIZIN)
Product Characteristics
Color blue Score
Shape Size
Flavor WINTERGREEN Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-0615-9 1 TUBE in 1 CARTON contains a TUBE
1 7 g in 1 TUBE This package is contained within the CARTON (11822-0615-9)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 05/06/2020
Labeler — Rite Aid (014578892)
Registrant — Lornamead (080046418)
Establishment
Name Address ID/FEI Operations
Lornamead 080046418 manufacture (11822-0615)

Revised: 10/2021 Rite Aid

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.