ANTIFUNGAL- miconazole nitrate cream 
Proficient Rx LP

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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Miconazole Nitrate Cream - Antifungal Cream

Drug Facts

Active ingredient

Miconazole nitrate, USP 2%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
for effective relief of itching, scaling, cracking, burning and discomfort

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

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

 Directions

wash the affected area and dry thoroughly
apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
supervise children in the use of this product
for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
if condition lasts longer, contact a doctor
this product is not effective on the scalp or nails

Other information

store at controlled room temperature 59°-86°F (15°-30°C).
before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

 1-800-432-8534 between 9 am and 4 pm EST, Monday- Friday.

Distributed by: Actavis

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Principal Display Panel


NDC 63187-885-15
Compare to the active ingredient in Micatin® Antifungal Cream 

Antifungal Cream
Miconazole Nitrate Cream, USP 2%
Soothes Itching, Scaling, Cracking, and Burning 

Cures Most Athlete’s Foot, Jock Itch & Ringworm 

Net wt. 0.5 oz (14g)

63187-885-15
ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-885(NDC:0472-0735)
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
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63187-885-151 in 1 CARTON09/01/2017
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/01/2007
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(63187-885)

Revised: 4/2021
Document Id: bb56f31c-5b87-409e-b5ec-bc410c4607e0
Set id: 5e619dfa-4401-45bb-83c6-aaaa59203e5e
Version: 4
Effective Time: 20210401
 
Proficient Rx LP