SOOTHE AND COOL TREAT- miconazole nitrate cream 
Medline Industries, 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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080 INZO Antifungal Cream

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

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
  • thereis 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

Other information

Inactive ingredients

allantoin, bees wax, cetyl dimethicone, cetyl PEG/PGG-10/1 dimethicone, dimethicone, fragrance, hydrogenated castor oil, imidazolidinyl urea, isopropyl palmitate, petrolatum, polymethoxy bicyclic oxazolidine, sodium chloride, water, zinc oxide

Manufacturing Information

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com
1-800-MEDLINE (633-5463)

REF: MSC095635

V1 RH22SAP

Package Label

Label V1 RH22SAP

SOOTHE AND COOL TREAT 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
5-HYDROXYMETHYL(METHYLENEOXY)-1-AZA-3,7-DIOXABICYCLO(3,3,0)OCTANE (UNII: 82EKS47IC5)  
ALLANTOIN (UNII: 344S277G0Z)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
IMIDUREA (UNII: M629807ATL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-080-57141 g in 1 TUBE; Type 0: Not a Combination Product01/01/2007
2NDC:53329-080-5856 g in 1 TUBE; Type 0: Not a Combination Product01/01/200704/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00501/01/2007
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 0322128b-e1f9-6f53-e063-6394a90afc29
Set id: 2915e550-a446-66b3-e054-00144ff8d46c
Version: 8
Effective Time: 20230817
 
Medline Industries, LP