FAMILY DOLLAR ORAL PAIN RELIEF- benzocaine liquid 
Family Dollar Services Inc.

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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5820388 Family Wellness Max Str Oral Pain Relief

Drug Facts

Active ingredient

Benzocaine 20% (W/W)

Purpose

Oral anesthetic

Use

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

  • 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

Adults and children 2 years of age and older:

children under 2 years of age: do not use

Other information

Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

MADE IN CANADA

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

10611 MONROE RD.

MATTHEWS, NC 28105

Card R2FAMILY WELLNESS

MAXIMUM STRENGTH

Oral Pain Relief

20% Benzocaine

Liquid Anesthetic

0.5 FL OZ (14.7 mL)

FAMILY DOLLAR  ORAL PAIN RELIEF
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-388
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Colororange (orange to reddish orange) Score    
ShapeSize
FlavorPINEAPPLE (Pina Colada Flavor 26041) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-388-821 in 1 CARTON08/01/201303/23/2023
114.7 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/01/2013
Labeler - Family Dollar Services Inc. (024472631)
Registrant - Lornamead (078584069)
Establishment
NameAddressID/FEIBusiness Operations
CSR Cosmetic Solutions Inc.243501959manufacture(55319-388)

Revised: 6/2023
Document Id: fe07ad15-d59e-237d-e053-6294a90a9776
Set id: ddd0a678-3cee-42a1-a34e-a870e2dd4a4f
Version: 7
Effective Time: 20230613
 
Family Dollar Services Inc.