ATHLETES FOOT- clotrimazole cream

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

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Active ingredient:
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)
Available from:
The IBN SINA Pharmaceutical Industry Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antifungal Uses - cures most athlete's foot, jock itch and ringworm - relieves itching, burning, cracking, scaling and discomfort which accompany these conditions Do not use on children under 2 years of age except under the advice and supervision of 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)
Authorization status:
OTC monograph final
Authorization number:
72103-527-10

ATHLETES FOOT- clotrimazole cream

The IBN SINA Pharmaceutical Industry Ltd.

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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Athlete's Foot

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

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 except under the advice and supervision of a doctor

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)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-

800-222-1222) right away.

Directions

wash the 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 the spaces between the toes

wear well-fitting ventilated shoes

change shoes and 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, consult a doctor

this product is not effective on the scalp or nails

Other information

store at 2° - 30° C (36° - 86° F)

Lot No. & Exp. Date: see box or see crimp of tube

Inactive ingredients

cetostearyl alcohol, methylparaben, mineral oil, paraffin, polyoxyl 40 hydrogenated castor oil,

polysorbate 80, water

Questions?

Call 1-833-IBN-SINA (1-833-426-7462)

Manufactured by:

The IBN SINA Pharmaceutical Industry Ltd.

Holding # A-80, Ward # 9, Shafipur, Kaliakoir

Gazipur-1751 Bangladesh

www.ibns inapharma.com

Product of Bangladesh

NDC 72103-527-10

Athlete's Foot!

Clotrimazole Cream, USP 1%

Antifungal Cream

Net Wt. 0.35 oz (10g)

Cures Most Athlete's Foot

ATHLETES FOOT

clotrimazole cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7210 3-527

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

The IBN SINA Pharmaceutical Industry Ltd.

Inactive Ingredients

Ingredient Name

Stre ng th

METHYLPARABEN (UNII: A2I8 C7HI9 T)

MINERAL O IL (UNII: T5L8 T28 FGP)

PARAFFIN (UNII: I9 O0 E3H2ZE)

PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7210 3-527-10

1 in 1 CARTON

0 3/14/20 19

1

10 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 3/14/20 19

Labeler -

T he IBN SINA Pharmaceutical Industry Ltd. (731557752)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

The Ibn Sina Pharmaceutical Industry Ltd.

731557752

ma nufa c ture (7210 3-527)

Revised: 3/2019

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