Jock Itch Cream

Jock Itch Cream
SPL v1
SPL
SPL Set ID 84129414-99ce-55c7-e053-2991aa0aadbc
Route
TOPICAL
Published
Effective Date 2019-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Methylparaben Mineral Oil Paraffin Polyoxyl 40 Hydrogenated Castor Oil Polysorbate 80 Cetostearyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-03-14

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

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

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
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store at 2° - 30° C (36° - 86° 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 (1-800-222-1222) right away.

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 except under the advice and supervision of a doctor

Section 51727-6

Inactive ingredients

cetostearyl alcohol, methylparaben, mineral oil, paraffin, polyoxyl 40 hydrogenated castor oil, polysorbate 80, water

Section 51945-4

NDC 72103-525-10

Jock Itch Cream

Clotrimazole Cream, USP 1%

Antifungal Cream

Net Wt. 0.35 oz (10g)

Cures Most Jock Itch

Section 53413-1

Questions?

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

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

Clotrimazole 1%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store at 2° - 30° C (36° - 86° 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 (1-800-222-1222) right away.

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 except under the advice and supervision of a doctor

Section 51727-6 (51727-6)

Inactive ingredients

cetostearyl alcohol, methylparaben, mineral oil, paraffin, polyoxyl 40 hydrogenated castor oil, polysorbate 80, water

Section 51945-4 (51945-4)

NDC 72103-525-10

Jock Itch Cream

Clotrimazole Cream, USP 1%

Antifungal Cream

Net Wt. 0.35 oz (10g)

Cures Most Jock Itch

Section 53413-1 (53413-1)

Questions?

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

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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