OLP CLOTRIMAZOLE- clotrimazole cream 
OHIO LAB PHARMA

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.

----------

ACTIVE INGREDIENT

Clotrimazole 1%

PURPOSE

Antifungal

USES

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

For external use only

Do not use:

  • 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 your doctor if:

  • rritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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

  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a

doctor

  • supervise children in the use of this product
  • 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 lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

Other information

  • store at controlled room temperature 59°-86°F (15°-30°C).
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

sodium cetostearyl sulfate, cetostearyl alcohol, stearic acid, trolamine, octyldodecanol, ceteareth-12, propylene glycol, methyl parabeen, propyl paraben, EDTA disodium, vitamin E, water

Questions

www.ohiolabpharma.us

PACKAGE LABEL

clotrimazole

OLP CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70648-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70648-500-011 in 1 CARTON02/01/2017
120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/01/201708/01/2017
Labeler - OHIO LAB PHARMA (080215854)
Registrant - OHIO LAB PHARMA (080215854)
Establishment
NameAddressID/FEIBusiness Operations
OHIO LAB PHARMA080215854manufacture(70648-500)

Revised: 8/2020
 
OHIO LAB PHARMA