4x Medicated Toothache and Gum Gel: Package Insert and Label Information

4X MEDICATED TOOTHACHE AND GUM GEL- benzocaine, benzalkonium chloride, menthol, unspecified form and zinc chloride gel
Walgreens

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

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

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

do not use if tip is cut rpior 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 glycerrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid

Carton Artwork
(click image for full-size original)

4X MEDICATED TOOTHACHE AND GUM GEL
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6008
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 g
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 0.5 g in 100 g
ZINC CHLORIDE (ZINC CATION) ZINC CATION 0.15 g in 100 g
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
AMMONIUM GLYCYRRHIZATE (GLYCYRRHIZIN)
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
SORBIC ACID
SACCHARIN SODIUM (SACCHARIN)
METHYL SALICYLATE
Product Characteristics
Color blue Score
Shape Size
Flavor WINTERGREEN Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-6008-89 1 TUBE in 1 CARTON contains a TUBE
1 7.1 g in 1 TUBE This package is contained within the CARTON (0363-6008-89)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/02/2020
Labeler — Walgreens (008965063)
Registrant — Lornamead (126440440)
Establishment
Name Address ID/FEI Operations
Lornamead 080046418 manufacture (0363-6008)

Revised: 06/2020 Walgreens

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