FAMILY WELLNESS PAIN RELIEF- benzocaine 20% gel

Family Wellness Pain Relief by

Drug Labeling and Warnings

Family Wellness Pain Relief by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR (Family Wellness), Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Fact 

Active Ingredient 

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

• temporary relief of occasional minor irritation, pain and sore mouth

Warnings 

Methemoglobinema Warning:Use of this product may cause Methemoglobinema, a serious condition that must be treated promptly becasue it reduces the amount of oxygem carried in the blood. This can occur even if you have used this product before. Stop use and seek immeditate medical attention if you or a child in yuor 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

Stop use and ask a Doctor if

swelling, rash or fever develops
irritation, pain, or redness persists or worsens

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not use tube if it is cut prior to opening
• cut open tip of tube on score mark
• use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
• apply to affected area up to four times daily or as directed by a dentist or physician
• Adults and children 2 years of age and older: Apply to affected area
• Children under 12 years of age should be supervised in the use of this product
• Children under 2 years of age: Consult a doctor

Inactive Ingredients 

Benzyl Alcohol, Carbomer, D&C Yellow No 10, FD&C Blue No 1, FD&C Red No 40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

Other information 

store at a controlled room temperature 68°- 77°F (20°-25°C)

Principal Display Panel 

NDC: 55319-157-33

Family Wellness 

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20% NET WT. 0.33 OZ (9.35g)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS PAIN RELIEF 
benzocaine 20% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-157
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-157-33	1 in 1 CARTON	01/15/2026
1		9.35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/15/2026

Labeler - FAMILY DOLLAR (Family Wellness) (024472631)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(55319-157) , analysis(55319-157)