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:
Kareway Product, Inc.
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 - irritation occurs - there is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch) - do not use for diaper rash
Authorization status:
OTC monograph final
Authorization number:
67510-0638-1

CLOTRIMAZOLE- clotrimazole cream

Kareway Product, Inc.

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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Soundbody Clotrimazole

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

Do not use on children under 2 years of age except under the advice and supervision of a doctor

For external use only

When using this product

avoid contact with the eyes

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)

do not use for diaper rash

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 cover affected area twice daily (morning and night) or as directed by a doctor

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 shoes and socks at least once a day

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

if conditions persist longer, ask a doctor

this product is not effective on the scalp or nails

Other information

store between 2°and 30° C (36° and 86° F)

Inactive ingredients

butylated hydroxytoluene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glyceryl stearate,

propylene glycol, sodium lauryl sulfate, stearic acid, water

Clotrimazole

CLOTRIMAZOLE

clotrimazole cream

Kareway Product, Inc.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7510 -0 6 38

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CLO TRIMAZO LE (UNII: G0 7GZ9 7H6 5) (CLOTRIMAZOLE - UNII:G0 7GZ9 7H6 5)

CLOTRIMAZOLE

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

GLYCERYL 1-STEARATE (UNII: 258 49 1E1RZ)

CARBO MER 9 4 0 (UNII: 4Q9 3RCW27E)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

ETHYLPARABEN (UNII: 14255EXE39 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7510 -0 6 38 -1

1 in 1 BOX

0 8 /27/20 18

1

28 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 mo no graph final

pa rt333C

0 8 /11/20 11

Labeler -

Kareway Product, Inc. (121840057)

Revised: 4/2019

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