CLEARLY CONFIDENT- miconazole nitrate cream 
Ultra Seal Corporation

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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Clearly Confident Drug Facts

Active Ingredient: Miconazole Nitrate (2.0%)   

Purpose: Anti Fungal

Uses

  • Helps cure most athlete’s foot
  • Also relieves: Itching, Scaling, Cracking, Redness, Soreness, Burning, Any irritation which accompanies these conditions

Directions

  • Supervise children in the use of this product
  • Clean affected area with soap and water and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • Use applicator tools to work product around edge of nails.
  • For athlete’s foot, pay attention to areas in between the toes. Wear wellfitting, ventilated shoes and change shoes and socks at least once daily.
  • For athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor
  • This product is not effective on the scalp or on nails.

Warnings

For external use only.

  • Do not use on children under the age of 2 without a physician’s advice.
  • When using this product avoid contact with eyes.
  • Do not use for diaper rash
  • Stop use and consult a physician, if athlete’s foot or ringworm persist for more than 4 weeks.

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

bacillus ferment, butylparaben, c13-14 Isoparaffin, caprylic/capric triglyceride, emu oil, ethylparaben, fragrance, isobutylparaben, laureth-7, methylparaben, phenoxyethanol, polyacrylamide, Propylparaben, titanium Dioxide, water.

Clearly Confident Carton

CLEARLY CONFIDENT 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-398
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
EMU OIL (UNII: 344821WD61)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
BACILLUS COAGULANS (UNII: ISK1LOY57E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LAURETH-4 (UNII: 6HQ855798J)  
VANILLA (UNII: Q74T35078H)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
WATER (UNII: 059QF0KO0R)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42213-398-481 in 1 CARTON12/17/201312/01/2022
1NDC:42213-398-2828 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/17/201312/01/2022
Labeler - Ultra Seal Corporation (085752004)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004pack(42213-398)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(42213-398)

Revised: 1/2023
 
Ultra Seal Corporation