FAMILY WELLNESS ORAL PAIN RELIEF- benzocaine 20% gel 
FAMILY DOLLAR SERVICES INC

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Benzocaine 20% pain relieving gel

Active ingredients

Benzocaine 20%

Purpose

Oral pain reliever

Uses

temporarily relieves pain associated with the following mouth and gum irritations:

Warnings

Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in 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:

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:

When using this product:

  • avoid contact with the eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness lasts or worsens
  • swelling, rash, or fever develops

Keep out of reach of children

Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and overapply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist
children under 12 years of ageadult supervision should be given in the use of this product
children under 2 years of agedo not use

Other information

Inactive ingredients

benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid

PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS  ORAL PAIN RELIEF
benzocaine 20% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-108-141 in 1 CARTON02/01/2024
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02202/01/2024
Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Revised: 2/2024
Document Id: 105d87d6-9148-43d4-e063-6394a90a57ee
Set id: 105d87d6-9147-43d4-e063-6394a90a57ee
Version: 1
Effective Time: 20240201
 
FAMILY DOLLAR SERVICES INC