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

Description

Benzocaine 20%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Benzocaine 20%

Uses

For the temporary relief of pain and itching.

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.

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

Package Labeling

Active Ingredient

Benzocaine 20%

Other Information

Store below 77° F (25° C). Avoid

direct sunlight.


Structured Label Content

Uses (USES)

For the temporary relief of pain and itching.

Purpose (PURPOSE)

Topical Anesthetic

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.

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

Package Labeling (PACKAGE LABELING)

Active Ingredient (ACTIVE INGREDIENT)

Benzocaine 20%

Other Information (OTHER INFORMATION)

Store below 77° F (25° C). Avoid

direct sunlight.


Advanced Ingredient Data


Raw Label Data

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