AZOLEN- miconazole nitrate liquid 
STRATUS PHARMACEUTICALS INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AZOLEN™

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Purpose

Topical Antifungal

Uses

Warnings

for external use only

Do not use

  • on children under 2 years of age unless directed by a doctor
  • for diaper rash

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks (for jock itch)
  • there is no improvement within 4 weeks (for athlete's foot and ringworm)

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately

Directions

Other Information

Inactive Ingredients

Lauramidopropyl Betaine, Laureth-7, Panthenol, Phospholipid EFA, Purified Water, Sodium Chloride, Sodium C14-16 Olefin Sulfonate, Tea Tree Oil.

Questions or Comments?

Call us at 1-800-442-7882

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 170 g Bottle Box

NDC 58980-819-60

AZOLEN™
ANTI-FUNGAL WASH

(MICONAZOLE NITRATE 2%)

NOW TREAT
JOCK ITCH IN
THE SHOWER

SOOTHES AND
CONTROLS MOST:*
JOCK ITCH
ATHLETE'S FOOT
RINGWORM

STRATUS
PHARMACEUTICALS INC

Net Wt 6 oz (170 g)

Principal Display Panel - 170 g Bottle Box
AZOLEN 
miconazole nitrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-819
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PANTHENOL (UNII: WV9CM0O67Z)  
TEA TREE OIL (UNII: VIF565UC2G)  
LAURETH-7 (UNII: Z95S6G8201)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-819-601 in 1 BOX09/14/2023
1170 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C09/14/2023
Labeler - STRATUS PHARMACEUTICALS INC (789001641)
Establishment
NameAddressID/FEIBusiness Operations
TARMAC PRODUCTS INC059890491MANUFACTURE(58980-819)

Revised: 9/2023
Document Id: 2e94984c-a24d-46df-8d98-4051110efe75
Set id: 3264bd0a-c628-404b-8c09-8586682d054e
Version: 1
Effective Time: 20230907
 
STRATUS PHARMACEUTICALS INC