PM EXTERNAL- econazole nitrate, salicylic acid, lidocaine, l-menthol solution

PM EXTERNAL by

Drug Labeling and Warnings

PM EXTERNAL by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ECONAZOLE NITRATE, SALICYLIC ACID, LIDOCAINE, L-MENTHOL

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & 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

WARNINGS

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.

INACTIVE INGREDIENT

acetone, chloroxylenol, water

DOSAGE & ADMINISTRATION

For external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PM EXTERNAL 
econazole nitrate, salicylic acid, lidocaine, l-menthol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72689-0038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	20 mg  in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	100 mg  in 1 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	20 mg  in 1 mL
ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M)	ECONAZOLE NITRATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETONE (UNII: 1364PS73AF)
CHLOROXYLENOL (UNII: 0F32U78V2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72689-0038-1	70 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/15/2018

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS TRADING		689991468	manufacture(72689-0038)