Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4d553377-efec-4b6d-822c-46c301894d18
Route
TOPICAL
Published
Effective Date 2014-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Methylparaben Mineral Oil Ceresin Petrolatum Propanediol Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-07-15

Description

Benzocaine 20%

Purpose

Oral Pain Reliever


Medication Information

Purpose

Oral Pain Reliever

Description

Benzocaine 20%

Uses

for the temporary relief of pain associated with:

■ toothache ■ canker sores ■ cold sores ■ fever blisters ■ minor dental procedures

Warnings

Allergy alert: do not use this product if your child has a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Directions

Adults and children 2 years of age and older:■ cut open tip of tube ■ apply to affected area up to 4 times daily or as directed by a dentist or physician ■ children under 12 years of age should be supervised using this product ■ for infants under 2 years of age, ask a doctor or health care provider

Do Not Use

■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider.

Package Label

Active Ingredient

Benzocaine 20%

Other Information

■ store at 59 to 77F (15-25C) ■ do not use if tube tip is cut prior to opening

Inactive Ingredients

Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

When Using This Product

■ fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician

Stop Use and Aska Doctor If

■ sore mouth symptoms do not get better in 7 days ■ irritation, pain or redness does not go away ■ swelling, rash or fever develops

Keep Out of Reach of Children

In case of overdose or allergic reaction get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

for the temporary relief of pain associated with:

■ toothache ■ canker sores ■ cold sores ■ fever blisters ■ minor dental procedures

Purpose

Oral Pain Reliever

Warnings

Allergy alert: do not use this product if your child has a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Directions

Adults and children 2 years of age and older:■ cut open tip of tube ■ apply to affected area up to 4 times daily or as directed by a dentist or physician ■ children under 12 years of age should be supervised using this product ■ for infants under 2 years of age, ask a doctor or health care provider

Do Not Use (Do not use)

■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider.

Package Label

Active Ingredient

Benzocaine 20%

Other Information (Other information)

■ store at 59 to 77F (15-25C) ■ do not use if tube tip is cut prior to opening

Inactive Ingredients (Inactive ingredients)

Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

When Using This Product (When using this product)

■ fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician

Stop Use and Aska Doctor If (Stop use and aska doctor if)

■ sore mouth symptoms do not get better in 7 days ■ irritation, pain or redness does not go away ■ swelling, rash or fever develops

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 immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)