Your browser does not support JavaScript! PRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]
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PRO-EX ANTI FUNGAL (clotrimazole) cream
[Natureplex, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active Ingredients
Clotrimazole 1%

Purpose
Antifungal

Uses
  • cures most jock itch
  • relieves itching, burning, cracking,scaling and discomfort 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 eyes

Stop use and ask a doctor if
  •  irritation occurs
  •  there is no improvement within 2 weeks

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

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over the affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp and nails

Other Information
  • Store between 15 and 30 C (59 and 86 F)
  • Do not use if seal on tube is punctured or missing

Inactive Ingredients
Aloe barbadensis (aloe) leaf juice, carbomer, cetyl alcohol, DMDM Hydantoin, glyceryl stearate, methylparaben, mineral oil, polysorbate 20, propylparaben, stearic acid, triethanolamine, trisodium edta, water

Pro EX artPACKAGE  LABEL

Antifungal Cream
Clotrimazole cream
Cures Most Jock Itch
Relieves Itching, Burning and Chafing
Compare to Lotrimin AF


PRO-EX  ANTI FUNGAL
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67234-014
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (Clotrimazole) Clotrimazole0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CARBOMER HOMOPOLYMER TYPE C 
CETYL ALCOHOL 
DMDM HYDANTOIN 
GLYCERYL MONOSTEARATE 
METHYLPARABEN 
MINERAL OIL 
POLYSORBATE 20 
PROPYLPARABEN 
STEARIC ACID 
TROLAMINE 
EDETATE TRISODIUM 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-014-0142 g in 1 TUBE
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

Revised: 2/2012
 
Natureplex, LLC

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