PRIVATE LABEL ANTIFUNGAL BARRIER CREAM- 2% miconazole nitrate cream cream 
Swiss-American CDMO, LLC

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Antifungal Barrier Cream

Warnings

For external use only. Not intended for ingestion. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. For the treatment of athlete’s foot and ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For the treatment of jock itch: if irritation occurs or there is no improvement within 2 weeks discontinue use and consult a doctor. Do not use for diaper rash. Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Use and Directions

Proven clinically effective in the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea sorporis). For the treatment of superficial skin infections caused by yeast (candida albicans). For effective relief of redness, irritation, scaling, itching, discomfort and burning.

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily as directed by a doctor or health care professional. 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 persists longer, consult a doctor. This product is not effective on the scalp or nails.

Keep out of reach of children

Keep out of reach of children

Active Ingredient

Miconazole Nitrate 2.00%

Inactive Ingredient

Allantoin, Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Fragrance, Hydrogenated Castor Oil, Isopropyl Palmitate, Methylparaben, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride, Zinc Oxide

Labeling

PL009 Artwork

PRIVATE LABEL ANTIFUNGAL BARRIER CREAM 
2% miconazole nitrate cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIMETHICONE 1000 (UNII: MCU2324216)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CUCUMBER (UNII: YY7C30VXJT)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60232-0009-260 g in 1 TUBE; Type 0: Not a Combination Product11/22/2010
2NDC:60232-0009-4120 g in 1 TUBE; Type 0: Not a Combination Product11/22/2010
3NDC:60232-0009-5150 g in 1 TUBE; Type 0: Not a Combination Product11/22/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/22/2010
Labeler - Swiss-American CDMO, LLC (080170933)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(60232-0009)

Revised: 11/2023
Document Id: 6f337fb6-6e77-4f2d-8c68-b54dbb366947
Set id: e74bddea-c1ac-4e4e-84bd-5a9defb85b2d
Version: 3
Effective Time: 20231107
 
Swiss-American CDMO, LLC