PRO-EX ANTI FUNGAL- clotrimazole cream 
Natureplex, LLC

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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PRO-EX
Anti Fungal

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Warnings

For external use only.

Avoid contact with eyes.

Do not use on children under 2 years of age unless directed by a doctor.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Other information

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 42 g Tube Carton

Natureplex™

NATUREPLEX
QUALITY
GUARANTEED

Pro-Ex
clotrimazole cream

NET WT. 1.5 Oz.
(42g)

Principal Display Panel - 42 g Tube Carton
PRO-EX  ANTI FUNGAL
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-014-0142 g in 1 TUBE; Type 0: Not a Combination Product01/22/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/22/2008
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex, LLC062808196manufacture(67234-014)

Revised: 11/2017
Document Id: 2af194fd-04d0-4c5b-b387-024a7903c0b1
Set id: be06dd85-e342-4f07-b0e4-c49b3f6b3b4b
Version: 12
Effective Time: 20171130
 
Natureplex, LLC