CLOTRIMAZOLE CREAM 1%- clotrimazole cream 1% cream 
SOLA Pharmaceuticals

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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Clotrimazole Cream 1% - Antifungal Cream

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Usage

Warnings

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

For external use only.

Avoid contact with eyes.

If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch), discontinue use and consult a doctor.

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Keep this and all drugs our of the reach of children. In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Cetomacragol 1000, Cetostearyl alcohol, Liquid paraffin, Methyl Paraben, Propyl paraben, Propylene glycol, Purified water, White soft paraffin.

Other Information

Questions or comments?

Call 1-866-747-7365

Package Display Panel

Questions or comments?

Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810


Store in a dry, cool place


For Comments or Questions, call 866-747-7365

Clotrimazole 1% Cream

NDC 70512-100-30


Qty: 28.4g

Clotrimazole AF boxClotrimazole generic boxClotrimazole tube

NDC 70512-100-15

QTY 14.2

15gm box

CLOTRIMAZOLE CREAM 1% 
clotrimazole cream 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-100
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
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70512-100-301 in 1 CARTON04/14/2020
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70512-100-151 in 1 CARTON10/21/2021
214.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/14/2020
Labeler - SOLA Pharmaceuticals (080121345)

Revised: 7/2022
Document Id: e314d3ba-c23e-39c0-e053-2995a90a7ca9
Set id: a3424c66-68ee-0631-e053-2995a90a3e7a
Version: 4
Effective Time: 20220705
 
SOLA Pharmaceuticals