Your browser does not support JavaScript! RITE AID ANTIFUNGAL RINGWORM (CLOTRIMAZOLE) CREAM [RITE AID CORPORATION]
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RITE AID ANTIFUNGAL RINGWORM (clotrimazole) cream
[Rite Aid Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • cures most ringworm
  • relieves itching, redness, irritation and discomfort which accompany this condition

Warnings

For external use only

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 4 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20°- 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

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:
RITE AID, 30 HUNTER LANE
CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

RITE
AID®
PHARMACY

antifungal ringworm cream

clotrimazole cream USP, 1%

cures most ringworm
relieves itching, redness, & irritation
for adults & children 2 years and older

NET WT 0.5 OZ (14.2 g)

Principal Display Panel - 14.2 g Tube Carton
RITE AID   ANTIFUNGAL RINGWORM
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-1110
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (Clotrimazole) Clotrimazole1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
cetostearyl alcohol 
cetyl esters wax 
octyldodecanol 
polysorbate 60 
water 
sorbitan monostearate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1110-11 in 1 CARTON
114.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C06/01/1995
Labeler - Rite Aid Corporation (014578892)
Registrant - Taro Pharmaceuticals U.S.A., Inc (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(11822-1110)

Revised: 1/2013
 
Rite Aid Corporation

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