ORAL PAIN RELIEF GEL- benzocaine 20% gel 
Sled Distribution, LLC

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 Pain Relief Gel

Drug Facts

Active ingredient

Benzocaine 20% (w/w)

Purpose

Oral anesthetic

Uses

For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Warnings

For oral use only.

stop use and ask a doctor if get any discomfort.

Stop use and ask a dentist or doctor if

Keep out of reach of children.

If accidentally swallowed get medical help or contact a Poison Control Center right away.

Directions

Adults and children (2 years and older):

Dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.

Inactive ingredients

Polyethylene Glycol, Fragrance

Benzocaine 20% | Oral Anesthetic

NET WT 0.75 g

label image

ORAL PAIN RELIEF GEL 
benzocaine 20% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81417-121-011 in 1 PACKAGE03/25/2022
10.75 g in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/25/2022
Labeler - Sled Distribution, LLC (079772888)
Establishment
NameAddressID/FEIBusiness Operations
Sled Distribution, LLC079772888manufacture(81417-121)

Revised: 3/2022
Document Id: 8a1fca56-0c73-4509-80fe-4dea3c764c52
Set id: 43af5b3f-4cda-4317-8c83-ff8d35786cb5
Version: 1
Effective Time: 20220325
 
Sled Distribution, LLC