Human Otc Drug Label

Human Otc Drug
SPL v2
SPL
SPL Set ID d7183409-f6ff-4915-e053-2a95a90a0979
Route
TOPICAL
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Water Polysorbate 60 Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-01-01

Description

Clotrimazole 1%


Medication Information

Warnings and Precautions

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.

Indications and Usage

Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).

Children under 2 years of age: consult a doctor

Dosage and Administration

10 milligrams/gram per application

Description

Clotrimazole 1%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

irritation occurs

there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Section 51727-6

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

Section 51945-4

Section 55105-1

Antifungal

cures most athlete's foot, jock itch and ringworm

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

Section 55106-9

Clotrimazole 1%

Section 59845-8

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 the 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

Section 60561-8

To open: unscrew cap, remove liner seal and replace cap

Store at USP controlled room temperature 20-25°C (68-77°F)

see carton or tube crimp for lot number and expiration date


Structured Label Content

Indications and Usage (34067-9)

Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).

Children under 2 years of age: consult a doctor

Dosage and Administration (34068-7)

10 milligrams/gram per application

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

irritation occurs

there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

cures most athlete's foot, jock itch and ringworm

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

Section 55106-9 (55106-9)

Clotrimazole 1%

Section 59845-8 (59845-8)

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 the 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

Section 60561-8 (60561-8)

To open: unscrew cap, remove liner seal and replace cap

Store at USP controlled room temperature 20-25°C (68-77°F)

see carton or tube crimp for lot number and expiration date


Advanced Ingredient Data


Raw Label Data

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