41dc85ec-d79b-0a32-e054-00144ff8d46c

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

Purpose

Topical Anesthetic

Description

Lidocaine HCL 4%


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.

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.

Description

Lidocaine HCL 4%

Package Labeling

Active Ingredient

Lidocaine HCL 4%


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.

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.

Package Labeling (PACKAGE LABELING)

Active Ingredient (ACTIVE INGREDIENT)

Lidocaine HCL 4%


Advanced Ingredient Data


Raw Label Data

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