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Lucky Oral Pain Relief

Medically reviewed on Nov 20, 2017

Dosage form: gel
Ingredients: BENZOCAINE 20g in 100g, BENZALKONIUM CHLORIDE 0.1g in 100g
Labeler: Delta Brands Inc
NDC Code: 20276-561

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.

Drug Facts

Active Ingredient

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Antiseptic

Uses

■ for the temporary relief of pain due to toothaches ■ to help protect against infectionin minor oral irritation

Warnings

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

Do not use

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

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

In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away

Directions

■ adults and children 2 years of age and over: apply a small amount of the 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: should be supervised in the use of this product ■ children under 2 years of age: ask a physician or health care provider

Other information

■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican 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, missing or if the tube tip is cut prior to opening

Inactive ingredients

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

Package Label

LUCKY  ORAL PAIN RELIEF
benzocaine benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-561
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE 
POLYETHYLENE GLYCOLS 
SACCHARIN SODIUM 
SORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:20276-561-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/2014
Labeler - Delta Brands Inc (102672008)

 
Delta Brands Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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