CAREONE CLOTRIMAZOLE- clotrimazole cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)
Available from:
American Sales Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antifungal - cures most athlete's foot, jock itch and ringworm - relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Authorization status:
OTC monograph final
Authorization number:
41520-305-02

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%

Purpos e

Antifungal

Us es

cures most athlete's foot, jock itch and ringworm

relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

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

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

for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated

shoes and change socks at least once daily

for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 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

Ques tions ?

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

RECOMMEND

NET WT 1 OZ (28.4 g)

Relieves Itching, Burning, Cracking & Scaling

CAREONE CLOTRIMAZOLE

clotrimazole cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41520 -30 5

Route of Administration

TOPICAL

American Sales Company

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Clo trima zo le (UNII: G0 7GZ9 7H6 5) (Clo trimazo le - UNII:G0 7GZ9 7H6 5)

Clo trima z o le

10 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

benzyl a lco ho l (UNII: LKG8 49 4WBH)

ceto stea ryl a lco ho l (UNII: 2DMT128 M1S)

cetyl esters wa x (UNII: D0 72FFP9 GU)

o ctyldo deca no l (UNII: 46 1N1O6 14Y)

po lyso rba te 6 0 (UNII: CAL22UVI4M)

wa ter (UNII: 0 59 QF0 KO0 R)

so rbita n mo no stea ra te (UNII: NVZ4I0 H58 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41520 -30 5-0 2

1 in 1 CARTON

0 8 /31/19 9 3

1

30 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333C

0 8 /31/19 9 3

Labeler -

American Sales Company (809183973)

Registrant -

T aro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Taro Pharmaceuticals Inc.

20 6 26 329 5

MANUFACTURE(41520 -30 5)

Revised: 4/2019

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