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
Purpose

Oral pain reliever

Description

Benzocaine 10%

Medication Information

Warnings

Methemoglobinemla: see package warning.

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
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

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

Active Ingredient

Benzocaine 10%

Structured Label Content

Warnings

Methemoglobinemla: see package warning.

Purpose

Oral pain reliever

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
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

Use
  • for the temporary relief of pain due to toothaches
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)

Active Ingredient (Active ingredient)

Benzocaine 10%

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