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

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.

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ECONAZOLE NITRATE, SALICYLIC ACID, LIDOCAINE, L-MENTHOL

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

■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

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.

acetone, chloroxylenol, water

For external use only

1

PM EXTERNAL 
econazole nitrate, salicylic acid, lidocaine, l-menthol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL20 mg  in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID100 mg  in 1 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE20 mg  in 1 mL
ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M) ECONAZOLE NITRATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETONE (UNII: 1364PS73AF)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0038-170 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/15/2018
Labeler - OASIS TRADING (689991468)
Registrant - OASIS TRADING (689991468)
Establishment
NameAddressID/FEIBusiness Operations
OASIS TRADING689991468manufacture(72689-0038)

Revised: 3/2019
Document Id: 846c196a-5b4e-08d4-e053-2991aa0a4d85
Set id: 846a49a1-c31e-73b9-e053-2a91aa0a0f95
Version: 1
Effective Time: 20190319
 
OASIS TRADING