CLEARLY CONFIDENT- miconazole nitrate cream

Clearly Confident by

Drug Labeling and Warnings

Clearly Confident by is a Otc medication manufactured, distributed, or labeled by Ultra Seal Corporation, Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Miconazole Nitrate (2.0%)   

PURPOSE

Purpose: Anti Fungal

INDICATIONS & USAGE

Uses

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

DOSAGE & ADMINISTRATION

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

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

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEARLY CONFIDENT 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42213-398
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42213-398-48	1 in 1 CARTON	12/17/2013
1	NDC: 42213-398-28	28 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - Ultra Seal Corporation (085752004)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(42213-398)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(42213-398)