FAMILY WELLNESS REGULAR- benzocaine 10% gel

Family wellness by

Drug Labeling and Warnings

Family wellness by is a Otc medication manufactured, distributed, or labeled by Velocity Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzocaine 10%

Purpose

Oral pain reliever

Use

• for the temporary relief of pain due to toothaches

Warnings

Methemoglobinemla: see package warning.

DO NOT USE

Do not use

• more than directed
• for more than 7 days unless directed by a physician or healthcare provider
• For teething
• in children under 2 year of age.

ASK DOCTOR

Stop use and ask a physician if

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN:

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions - cut open tip of tube on score mark

• Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
• Children between 2 and 12 years of age - Should be supervised in the use of this product
• Children under 2 years of age - Ask a physicaian or healthcare provider

Other information

• do not use if tape seal on the flaps of outer packaging are damaged or miissing
• Retain outer packaging for full product uses,directions and warnings.

Inactive ingredients

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS  REGULAR
benzocaine 10% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-607
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-607-33	1 in 1 PACKAGE	07/02/2020
1		9 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 not final	part356	07/02/2020

Labeler - Velocity Pharma LLC (962198409)