CLEARLY CONFIDENT- miconazole nitrate cream 
Ganeden Biotech, 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.

----------

Ganeden Clearly Confident
Drug Facts

Active Ingredient:Active Ingredient....Miconazole Nitrate (2.0%)

Purpose:Anti Fungal

Uses

For effective treatment of fungus on

skin around and adjacent to the nails.

Helps cure most athlete’s foot and

ringworm. Also Relieves:

Itching Scaling Cracking

Redness Soreness Burning

Any irritation which accompanies

these conditions

Directions

Clean affected area with soap and

water. Apply a thin layer of the

product over affected area twice daily.

Use applicator tools to work product

around edge of nails

For athlete’s foot, pay attention to the

areas in between the toes.Wear wellfitting,

ventilated shoes and change

shoes and socks at least once daily.

Warnings

Read all package directions and

warnings before use.

For external use only.

If athlete’s foot or ringworm persist for

more than 4 weeks, discontinue use

and consult a physician.

Do not use on children under the age

of 2 without a physician’s advice.

Avoid contact with eyes.

Keep out of reach of children

None

Inactive Ingredients: Bacillus Ferment, Butylparaben, C13-14

Isoparaffin, Capryli/Capric Triglyceride,

Emu Oil, Ethylparaben, Fragrance,

Isobutyl Paraben, Laureth-7,

Methylparaben, Phenoxyethanol,

Polyacrylamide, Propylparaben,

Titanium Dioxide, Water.

MM1 Clearly FactsCC PDP

CLEARLY CONFIDENT 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65556-398
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
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65556-398-2828 g in 1 TUBE; Type 0: Not a Combination Product12/17/201311/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/17/201311/05/2019
Labeler - Ganeden Biotech, Inc. (826163979)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004repack(65556-398)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(65556-398)

Revised: 11/2019
 
Ganeden Biotech, Inc.