7d5f66e9-12b2-4251-861d-3ed354f76c31

SPL v2
SPL
SPL Set ID 7d5f66e9-12b2-4251-861d-3ed354f76c31
Route
topical
Published
Effective Date 2016-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (10 mg)
Inactive Ingredients
benzyl alcohol isopropyl myristate paraffin polysorbate 60 propylene glycol water sorbitan monostearate stearic acid stearyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-08-07

Description

Active ingredient                                                         Purpose Clotrimazole 1%--------------------------------------------- Antifungal


Medication Information

Warnings and Precautions

Warnings

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

For external use only

Active Ingredient

Active ingredient                                                         Purpose

Clotrimazole 1%--------------------------------------------- Antifungal

Indications and Usage

Direction

  • Wash affected area and dry thoroughly
  • Apply a thin layer over 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 condition persists longer, ask a doctor
  • This product is not effective on the scalp or nails
Dosage and Administration

DISTRIBUTED BY:

PRODUCTOS ZAPOTOL CORP.

Van Nuys, CA 91402

888-927-6865

Made in Korea

Description

Active ingredient                                                         Purpose Clotrimazole 1%--------------------------------------------- Antifungal

Section 44425-7

Other information

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

Store between 20°C to 25°C (68°F to 77°F)

Section 50565-1

Keep out of reach of childern

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

Section 50567-7

When using this product  avoid contact with the eyes

Section 50569-3

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

Section 51727-6

Inactive ingredients

benzyl alcohol, isopropyl myristate, liquid paraffin, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearic acid, stearyl alcohol

Section 51945-4

Section 55105-1

Uses

  • Cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

For external use only

Active Ingredient (55106-9)

Active ingredient                                                         Purpose

Clotrimazole 1%--------------------------------------------- Antifungal

Indications and Usage (34067-9)

Direction

  • Wash affected area and dry thoroughly
  • Apply a thin layer over 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 condition persists longer, ask a doctor
  • This product is not effective on the scalp or nails
Dosage and Administration (34068-7)

DISTRIBUTED BY:

PRODUCTOS ZAPOTOL CORP.

Van Nuys, CA 91402

888-927-6865

Made in Korea

Section 44425-7 (44425-7)

Other information

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

Store between 20°C to 25°C (68°F to 77°F)

Section 50565-1 (50565-1)

Keep out of reach of childern

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

Section 50567-7 (50567-7)

When using this product  avoid contact with the eyes

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

Inactive ingredients

benzyl alcohol, isopropyl myristate, liquid paraffin, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearic acid, stearyl alcohol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

  • Cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Advanced Ingredient Data


Raw Label Data

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