SELAN ANTIFUNGAL- selan antifungal cream 
Trividia Manufacturing Solutions, 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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Selan AntiFungal

Active Ingredients

Miconazole nitrate 2%

Purpose

Antifungal

Uses

 - Cures most jock itch (tinea cruris), ringworm (tinea corporis), athlete's foot (tinea pedis) and superficial yeast infections

 - Relieves itching, cracking, burning, redness, irritation and discomfort associated with these conditions

Warnings

For external use only

Do not use on children under 2 years old unless directed by a doctor

When using this product avoid contact with the eyes

Stop use and ask a doctor if irritation occurs or if there is no improvement

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

Directions

 - Clean affected area and dry thoroughly

 - Apply a thin layer over the affected area twice daily (morning and night) for 2 weeks (jock itch) or 4 weeks (athlete's foot & ringworm)

 - Supervise children in the use of this product

For athlete's foot  *pay special attention to the space between the toes  *wear well fitting, ventilated shoes  *change shoes and socks at least once daily

If condition persists longer, or if irritiation occurs, consult a doctor. This product is not effective on the scalp or nails.

Other information

store at room temperature

Inactive ingredients:

Dimethicone, emulsifying wax, fragrance, germaben II, lanolin, propylene glycol, water, zinc oxide

Image of 4oz tube

Selan Antifungal 4oz label

SELAN ANTIFUNGAL 
selan antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0159-2500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
LANOLIN (UNII: 7EV65EAW6H)  
DIMETHICONE 1000 (UNII: MCU2324216)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0159-2500-04117 g in 1 TUBE; Type 0: Not a Combination Product11/05/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/05/2003
Labeler - Trividia Manufacturing Solutions, Inc (018927392)
Establishment
NameAddressID/FEIBusiness Operations
Trividia Manufacturing Solutions, Inc018927392manufacture(0159-2500) , label(0159-2500) , pack(0159-2500)

Revised: 2/2022
Document Id: d8251a05-22ea-0eeb-e053-2995a90a08af
Set id: 8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a29
Version: 7
Effective Time: 20220216
 
Trividia Manufacturing Solutions, Inc