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Clearly Confident

Ganeden Biotech, Inc.
Ultra Seal Corporation

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Purpose:Anti Fungal

Uses

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.

MM1Clearly Confident Clearly Confident

Clearly Confident

Miconazole Nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65556-398
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE MICONAZOLE 20 mg

Inactive Ingredients

Ingredient Name Strength
titanium dioxide
PROPYLPARABEN
PHENOXYETHANOL
METHYLPARABEN
laureth-4
VANILLA
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65556-398-28 28 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2013-12-17


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