Label: PM EXTERNAL- econazole nitrate, salicylic acid, lidocaine, l-menthol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 72689-0038-1 - Packager: OASIS TRADING
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated March 19, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- INDICATIONS & USAGE
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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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PM EXTERNAL
econazole nitrate, salicylic acid, lidocaine, l-menthol solutionProduct 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)
