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Clearly Confident

Medically reviewed on Dec 18, 2017

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Ganeden Biotech, Inc.
NDC Code: 65556-398

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.

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 CONFIDENT 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65556-398
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
PROPYLPARABEN 
PHENOXYETHANOL 
METHYLPARABEN 
LAURETH-4 
VANILLA 
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES 
WATER 
Packaging
#Item CodePackage Description
1NDC:65556-398-2828 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/17/2013
Labeler - Ganeden Biotech, Inc. (826163979)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIOperations
Ultratab Laboratories, Inc.151051757manufacture(65556-398)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack(65556-398)

 
Ganeden Biotech, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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