3eea2171-850b-4045-e054-00144ff8d46c

SPL v8
SPL
SPL Set ID 3eea2171-850b-4045-e054-00144ff8d46c
Route
topical
Published
Effective Date 2016-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (20 g)
Inactive Ingredients
peg-100 stearate phenoxyethanol dimethicone water cetearyl olivate ethylhexylglycerin glyceryl stearate se peg-8 stearate petrolatum sorbitan olivate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-10-15

Purpose

Topical Anesthetic

Description

Benzocaine 20%


Medication Information

Warnings

• For external use only.

• Avoid contact with eyes or mucus membranes.

• Do not apply to open or damaged skin.

• If condition worsens or symptoms persist for

more than seven days, discontinue use and

consult physician.

• If pregnant or breast feeding,contact physician

prior to use.

• Keep out of reach of children. If swallowed,

contact Poison Control Center.

• Do not use if allergic to any ingredient in ointment.

• Do not use in large quantities, particularly over

raw surfaces or blistered areas.

Uses

For the temporary relief of pain and itching.

Purpose

Topical Anesthetic

Directions

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician

Other Information

Store below 77° F (25° C). Avoid

direct sunlight.

Description

Benzocaine 20%

Package Labeling

Active Ingredient

Benzocaine 20%


Structured Label Content

Warnings (WARNINGS)

• For external use only.

• Avoid contact with eyes or mucus membranes.

• Do not apply to open or damaged skin.

• If condition worsens or symptoms persist for

more than seven days, discontinue use and

consult physician.

• If pregnant or breast feeding,contact physician

prior to use.

• Keep out of reach of children. If swallowed,

contact Poison Control Center.

• Do not use if allergic to any ingredient in ointment.

• Do not use in large quantities, particularly over

raw surfaces or blistered areas.

Uses (USES)

For the temporary relief of pain and itching.

Purpose (PURPOSE)

Topical Anesthetic

Directions (DIRECTIONS)

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician

Other Information (OTHER INFORMATION)

Store below 77° F (25° C). Avoid

direct sunlight.

Package Labeling (PACKAGE LABELING)

Active Ingredient (ACTIVE INGREDIENT)

Benzocaine 20%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)