Family Wellness Oral Pain Relief Gel

Family Wellness Oral Pain Relief Gel
SPL v1
SPL
SPL Set ID a97a6682-49ec-477c-e053-2a95a90a0bec
Route
TOPICAL
Published
Effective Date 2020-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (100 mg)
Inactive Ingredients
Ammonium Glycyrrhizate Polyethylene Glycol 1000 Saccharin Sodium Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-02
Description

Benzocaine 10%

Purpose

Oral pain reliever

Medication Information

Purpose

Oral pain reliever

Dosage and 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
Description

Benzocaine 10%

Use
  • for the temporary relief of pain due to toothaches
Section 50565-1

KEEP OUT OF REACH OF CHILDREN:

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

Section 50569-3

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
Section 50570-1

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.
Section 51945-4

Warnings

Methemoglobinemla: see package warning.

Active Ingredient

Benzocaine 10%

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

Structured Label Content

Use
  • for the temporary relief of pain due to toothaches
Dosage and Administration (34068-7)

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
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN:

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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.
Section 51945-4 (51945-4)

Purpose

Oral pain reliever

Warnings

Methemoglobinemla: see package warning.

Active Ingredient (Active ingredient)

Benzocaine 10%

Other Information (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 (Inactive ingredients)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:06.642843 · Updated: 2026-03-14T22:57:30.442086