FAMILY DOLLAR ORAL PAIN RELIEF- benzocaine liquid

Family Dollar by

Drug Labeling and Warnings

Family Dollar by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services Inc., Lornamead, CSR Cosmetic Solutions Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzocaine 20% (W/W)

PURPOSE

Purpose

Oral anesthetic

INDICATIONS & USAGE

Use

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

• toothache
• sore gums
• canker sores
• braces
• minor dental procedures

WARNINGS

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:

• pale, gray, or blue colored skin(cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

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.

DOSAGE & ADMINISTRATION

Directions

Adults and children 2 years of age and older:

• apply to affected area using applicator tip
• use up to 4 times daily or as directed by a dentist or doctor
• children under 12 years of age should be supervised in the use of this product

children under 2 years of age: do not use

STORAGE AND HANDLING

Other information

• do not use if package has been opened
• store at 20 - 25 C (68-77F)
  

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

MADE IN CANADA

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

10611 MONROE RD.

MATTHEWS, NC 28105

PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS

MAXIMUM STRENGTH

Oral Pain Relief

20% Benzocaine

Liquid Anesthetic

0.5 FL OZ (14.7 mL)

INGREDIENTS AND APPEARANCE

FAMILY DOLLAR  ORAL PAIN RELIEF
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-388
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange (orange to reddish orange)	Score
Shape		Size
Flavor	PINEAPPLE (Pina Colada Flavor 26041)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-388-81	14.7 g in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/01/2013

Labeler - Family Dollar Services Inc. (024472631)

Registrant - Lornamead (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
CSR Cosmetic Solutions Inc.		243501959	manufacture(55319-388)