DYNAREX ANTIFUNGAL- antifungal cream 
Dynarex Corporation

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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1231, 1233

Active Ingredient

Active Ingredient                       Purpose

Clotrimazole 1.0%                     Antifungal                          

Purpose


Warnings

Do not use:

Indications and Usage

Dosage and Administration

Keep Out Of Reach Of Children

KEEP OUT Of REACH Of CHILDREN

INACTIVE INGREDIENTS

Inactive Ingredients: Cetomicrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraben

Label

1231 IN MASTER

Label

1233 BX MASTER

DYNAREX ANTIFUNGAL 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-231-1372 in 1 CASE05/18/2010
1NDC:67777-231-121 in 1 BOX
1NDC:67777-231-0228.25 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:67777-231-1124 in 1 CASE05/18/2010
2NDC:67777-231-106 in 1 BOX
2NDC:67777-231-01113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/18/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 11/2022
Document Id: eea09985-a17f-6468-e053-2a95a90a661b
Set id: ab5b6467-c158-4407-9d52-3c0731030680
Version: 8
Effective Time: 20221129
 
Dynarex Corporation