Family Care Clotrimazole Cream 1% 1 Oz 505

Family Care Clotrimazole Cream 1% 1 Oz 505
SPL v7
SPL
SPL Set ID 63255079-ecf1-1e77-e053-2a91aa0a7b6c
Route
TOPICAL
Published
Effective Date 2018-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Sulfite Ion Steareth-20 Stearic Acid Water Propylene Glycol Cetostearyl Alcohol Ethylparaben Glycerin Light Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-01

Description

Active ingredient Purpose Clotrimazole 1%.............................................................................Antifungal


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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 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, ask a doctor
  • this product is not effective on the scalp or nails
Dosage and Administration

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

Made in China

Description

Active ingredient Purpose Clotrimazole 1%.............................................................................Antifungal

Section 44425-7

Other information

  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube
Section 50565-1

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

Section 50566-9

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)
Section 50567-7

When using this product avoid contact with the eyes

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor

Section 51727-6

Inactive ingredients

cetostearly alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

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
Section 55106-9

Active ingredient Purpose

Clotrimazole 1%.............................................................................Antifungal


Structured Label Content

Indications and Usage (34067-9)

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 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, ask a doctor
  • this product is not effective on the scalp or nails
Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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)
Section 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor

Section 51727-6 (51727-6)

Inactive ingredients

cetostearly alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

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
Section 55106-9 (55106-9)

Active ingredient Purpose

Clotrimazole 1%.............................................................................Antifungal


Advanced Ingredient Data


Raw Label Data

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