OTC Medication Information: 3X Medicated Toothache and Gum Gel

3X MEDICATED TOOTHACHE AND GUM GEL- benzocaine, menthol and zinc chloride 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.

Acive Ingredients Purpose

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 minor irritation or injury of the mouth and gums

Methemoglobinemia warning: use of this product may cause methemoglobinema, a serious condition that must be treated promptly because it reduces the amount of oxygen in the blood. This can occur even if you have used this prouct 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 * 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

Directions * cut open tip of tube on score mark * do not use if tip is cut prior to opening * adults adn 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

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

Inactive ingredients ammonium glycyrrhizate, favor, PEG-8, PEG-75, sodium saccharin, sorbic acid

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20% benzocaine to relive oral pain

Astringent to help prevent infection

Menthol to soothe gums

3x medicated

oral pain reliever/astringent

Net Wt 0.42 oz (11.9 g)

3X MEDICATED TOOTHACHE AND GUM GEL
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0613
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g in 100 g
MENTHOL (MENTHOL) MENTHOL 0.26 g in 100 g
ZINC CHLORIDE (ZINC CATION) ZINC CATION 0.15 g in 100 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM (SACCHARIN)
POLYETHYLENE GLYCOL 400
SORBIC ACID
AMMONIUM GLYCYRRHIZATE (GLYCYRRHIZIN)
Product Characteristics
Color white (Cloudy white to beige) Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-0613-9 1 TUBE in 1 CARTON contains a TUBE
1 11.7 g in 1 TUBE This package is contained within the CARTON (11822-0613-9)
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)
Establishment
Name Address ID/FEI Operations
Lornamead 080046418 manufacture (11822-0613)

Revised: 05/2020 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.

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