CLOTRIMAZOLE- drs. clotrimazole cream 
OL PHARMA TECH,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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ACTIVE INGREDIENT

Clotrimazole 1%

PURPOSE

Antifungal

USES

warnings

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:

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

doctor

and change shoes and socks at least once daily

if condition lasts longer, contact a doctor

Other information

Inactive ingredients

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

For Questions:

www.drspharmacyusa.com

original strenghth

Antifungal cream

clotrimazole

CLOTRIMAZOLE 
drs. clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-002
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80489-002-011 in 1 CARTON01/01/2021
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2021
Labeler - OL PHARMA TECH,LLC (021170377)
Registrant - OL PHARMA TECH,LLC (021170377)
Establishment
NameAddressID/FEIBusiness Operations
OL PHARMA TECH,LLC (Drs, pharmacy)021170377manufacture(80489-002)

Revised: 10/2023
Document Id: 06b9af3e-eab0-b447-e063-6294a90acf54
Set id: b0e9fc77-6d5c-2472-e053-2995a90a3de4
Version: 3
Effective Time: 20231002
 
OL PHARMA TECH,LLC