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Soothe And Cool Treat

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 100g
Labeler: Medline Industries, Inc.
NDC Code: 53329-080

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.

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses
  • For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • For the treatment of superficial skin infections caused by yeast (candida albicans)
  • Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

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 ■ there is no improvement 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

■ Clean the affected area and dry thoroughly ■ Apply a thin layer over affected area twice daily or as directed by a physician ■ Supervise use by children ■ 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 four weeks ■ For jock itch, use daily for two weeks ■ If condition persists longer, consult a doctor ■ This product is not effective on scalp or nails

Other information
  • Protect from freezing. Avoid excessive heat.

Inactive ingredients

Allantoin, Bees Wax, Cetyl Dimethicone, Cetyl PEG/PGG-10/1 Dimethicone, Fragrance, Hydrogenated Castor Oil, Imidazolidinyl Urea, Isopropyl Palmitate, Petrolatum, Polymethoxy Bicyclic Oxazolidine, Sodium Chloride, Water, Zinc Oxide.

www.medline.com

Manufactured in USA for Medline Industries, Inc.,

Mundelein, IL 60060 USA. 1-800-MEDLINE RF15SAP

Principal Display Panel - 5 fl oz

NDC 53329-080-57

Soothe&Cool

TREAT

INZO Antifungal Cream

  • Miconazole Nitrate 2%
  • Treats fungal infections
  • Aids in maintaining healthy skin

5 ​oz (141.7 mL)

REF MSC095635

SOOTHE AND COOL TREAT 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-080
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL DIMETHICONE 25 
5-HYDROXYMETHYL(METHYLENEOXY)-1-AZA-3,7-DIOXABICYCLO(3,3,0)OCTANE 
ALLANTOIN 
YELLOW WAX 
HYDROGENATED CASTOR OIL 
DIMETHICONE 
ISOPROPYL PALMITATE 
PETROLATUM 
SODIUM CHLORIDE 
WATER 
ZINC OXIDE 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) 
IMIDUREA 
Packaging
#Item CodePackage Description
1NDC:53329-080-57141 g in 1 TUBE
2NDC:53329-080-5856 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2007
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIOperations
Swiss-American CDMO, LLC080170933manufacture(53329-080)

 
Medline Industries, Inc.

Medically reviewed on Dec 19, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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