SPL v1
SPL
SPL Set ID 846a49a1-c31e-73b9-e053-2a91aa0a0f95
Route
TOPICAL
Published
Effective Date 2018-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (20 mg) Salicylic Acid (100 mg) Lidocaine (10 mg) Econazole
Inactive Ingredients
Acetone Chloroxylenol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-11-15

Description

ECONAZOLE NITRATE, SALICYLIC ACID, LIDOCAINE, L-MENTHOL


Medication Information

Warnings and Precautions

For external use olny.

Flammable

■ Keep away from fire, flame, sparks and heated surfaces.

Tight cap firmly

Stop use and ask a doctor if

■ Condition worsens or symptoms persist for more than 7days or clear up and occur again within a few days

When using this product

■ use olny as direct

■ avoid contact with eyes

■ Do not apply to wounds or damage skin

■ do not bandage tightly

If pregnant or breast-feeding, ask a health professional before use

keep out of reach of children.

Indications and Usage

■First wash and dry your feet thoroughly

■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

■ children under 2 years of age: consult a doctor

Dosage and Administration

For external use only

Description

ECONAZOLE NITRATE, SALICYLIC ACID, LIDOCAINE, L-MENTHOL

Section 50565-1

Keep out of reach of children

Section 51727-6

acetone, chloroxylenol, water

Section 51945-4

Section 55105-1

When left untreated, the symptoms can be painful, unsightly, and make walking difficult.

Here are the most common symptoms:

Itching or burning between your toes or on the soles of your feet

White, wet-looking skin in between your toes

Flaky skin or small tears (fissures) on feet or in-between toes

Red rash between the toes

Blisters or ulcers on the skin on top of foot

Broken blisters, causing pain and swelling

Thick, dry, scaly skin on the bottom and sides of feet

Section 55106-9

ECONAZOLE NITRATE, SALICYLIC ACID, LIDOCAINE, L-MENTHOL


Structured Label Content

Indications and Usage (34067-9)

■First wash and dry your feet thoroughly

■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

■ children under 2 years of age: consult a doctor

Dosage and Administration (34068-7)

For external use only

Warnings and Precautions (34071-1)

For external use olny.

Flammable

■ Keep away from fire, flame, sparks and heated surfaces.

Tight cap firmly

Stop use and ask a doctor if

■ Condition worsens or symptoms persist for more than 7days or clear up and occur again within a few days

When using this product

■ use olny as direct

■ avoid contact with eyes

■ Do not apply to wounds or damage skin

■ do not bandage tightly

If pregnant or breast-feeding, ask a health professional before use

keep out of reach of children.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

acetone, chloroxylenol, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

When left untreated, the symptoms can be painful, unsightly, and make walking difficult.

Here are the most common symptoms:

Itching or burning between your toes or on the soles of your feet

White, wet-looking skin in between your toes

Flaky skin or small tears (fissures) on feet or in-between toes

Red rash between the toes

Blisters or ulcers on the skin on top of foot

Broken blisters, causing pain and swelling

Thick, dry, scaly skin on the bottom and sides of feet

Section 55106-9 (55106-9)

ECONAZOLE NITRATE, SALICYLIC ACID, LIDOCAINE, L-MENTHOL


Advanced Ingredient Data


Raw Label Data

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