Antifungal by A-S Medication Solutions Antifungal

Antifungal by

Drug Labeling and Warnings

Antifungal by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIFUNGAL- miconazole nitrate cream 
A-S Medication Solutions

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.

----------

Antifungal

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort

Warnings

For external use only

Ask a doctor before use

  • on children under 2 years of age

When using this product

  • avoid contact with 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

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • clean 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; change shoes and socks at least once daily

Other information

  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Questions?

Call 1-866-923-4914

Distributed by McKesson One Post Street
San Francisco, CA 94104

HOW SUPPLIED

Product: 50090-1351

Miconazole Nitrate

Label Image
ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-1351(NDC: 49348-689)
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
apricot kernel oil (UNII: 54JB35T06A)  
benzoic acid (UNII: 8SKN0B0MIM)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
glycol stearate (UNII: 0324G66D0E)  
mineral oil (UNII: T5L8T28FGP)  
polyethylene glycol 300 (UNII: 5655G9Y8AQ)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-1351-01 in 1 CARTON11/28/201402/28/2018
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C10/01/199102/28/2018
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-1351)

Revised: 1/2020
 
A-S Medication Solutions