ORAL GEL ORAL PAIN RELIEF- benzocaine benzalkonium chloride gel 
Savvy Care and Cosmetics

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.

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Oral gel

Active Ingredient

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Antiseptic

Use

■ 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

image description

ORAL GEL  ORAL PAIN RELIEF
benzocaine benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83650-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83650-101-0142.5 g in 1 TUBE; Type 0: Not a Combination Product09/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/22/2023
Labeler - Savvy Care and Cosmetics (915039748)
Establishment
NameAddressID/FEIBusiness Operations
Savvy Care and Cosmetics915039748manufacture(83650-101)

Revised: 9/2023
Document Id: 05ede7f5-7ab1-5348-e063-6394a90a72e9
Set id: 05ede7e4-5a0a-c942-e063-6294a90a8a24
Version: 1
Effective Time: 20230922
 
Savvy Care and Cosmetics