Ganeden Clearly Confident Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

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.

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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 CONFIDENT 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65556-398
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65556-398-28	28 g in 1 TUBE; Type 0: Not a Combination Product	12/17/2013	11/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/17/2013	11/05/2019

Labeler - Ganeden Biotech, Inc. (826163979)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	repack(65556-398)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(65556-398)

Revised: 11/2019

Document Id: 969df520-c2b0-0396-e053-2a95a90aa22e

34390-5

Set id: 72d368fc-c478-427d-a7f4-49f402e1a600

Version: 2

Effective Time: 20191105

 

Ganeden Biotech, Inc.