SPL v8
SPL
SPL Set ID 41dc85ec-d79b-0a32-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Glycerin Sunflower Oil Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Benzyl Alcohol Polysorbate 20 Cetyl Alcohol Yellow Wax Stearic Acid Dehydroacetic Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-21

Description

Lidocaine HCL 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine HCL 4%

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

Lidocaine HCL 4%

Other Information

Store below 77° F (25° C). Avoid

direct sunlight.

Inactive Ingredients

Acrylates, C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Beeswax, Benzyl Alcohol, Cetyl Alcohol, Dehydroacetic Acid, Glycerin, Helianthus Anuus (Sunflower) Oil, Polysorbate 20, Sodium Hydroxide, Stearic Acid.


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)

Lidocaine HCL 4%

Other Information (OTHER INFORMATION)

Store below 77° F (25° C). Avoid

direct sunlight.

Inactive Ingredients (INACTIVE INGREDIENTS)

Acrylates, C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Beeswax, Benzyl Alcohol, Cetyl Alcohol, Dehydroacetic Acid, Glycerin, Helianthus Anuus (Sunflower) Oil, Polysorbate 20, Sodium Hydroxide, Stearic Acid.


Advanced Ingredient Data


Raw Label Data

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