CAREONE  CLOTRIMAZOLE- clotrimazole cream 
American Sales Company

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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CAREONE™
Clotrimazole USP 1%

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

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 4 weeks (for athlete's foot or ringworm) or 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

Other information

Inactive ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

Call 1-866-923-4914

DISTRIBUTED BY:
FOODHOLD U.S.A.
LLC LANDOVER,
MD 20785

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

NDC 41520-305-02

CAREone®

Compare to the
active ingredient
in Lotrimin® AF*

Antifungal Cream
Clotrimazole Cream USP, 1% • Antifungal

Cures Most Athlete's Foot

OUR PHARMACISTS
RX
RECOMMEND

NET WT 1 OZ (28.4 g)

Relieves Itching, Burning, Cracking & Scaling •

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
CAREONE   CLOTRIMAZOLE
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-305
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
benzyl alcohol (UNII: LKG8494WBH)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetyl esters wax (UNII: D072FFP9GU)  
octyldodecanol (UNII: 461N1O614Y)  
polysorbate 60 (UNII: CAL22UVI4M)  
water (UNII: 059QF0KO0R)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-305-021 in 1 CARTON08/31/1993
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C08/31/1993
Labeler - American Sales Company (809183973)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(41520-305)

Revised: 4/2019
Document Id: 1d679f20-267c-4fae-a3c3-a9f0c3806d17
Set id: 68915156-8927-4ace-9497-5e510d1edcca
Version: 2
Effective Time: 20190417
 
American Sales Company