LEADER ATHLETES FOOT CLOTRIMAZOLE- clotrimazole cream 
LEADER

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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LEADER ATHLETE'S FOOT CREAM CLOTRIMAZOLE 1%

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

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

LEADER

NDC 70000-0542-2

Athlete's Foot Cream
Clotrimazole, 1% | Antifungal

Cures Most Athlete's Foot

Soothing and Cooling Cream
Enriched with Aloe

Contains the Drug Clotrimazole

COMPARE TO
LOTRIMIN® AF
active ingredient*

100% Money Back Guarantee

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
LEADER ATHLETES FOOT CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0542
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, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0542-21 in 1 CARTON01/17/2020
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70000-0542-11 in 1 CARTON01/22/2020
214 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C01/17/2020
Labeler - LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(70000-0542)

Revised: 6/2021
Document Id: 020cf38b-8d65-46d4-8ea7-246fd0acec6a
Set id: dcea717b-b097-4a40-8e38-05212731a7ef
Version: 2
Effective Time: 20210621
 
LEADER