1 % clotrimazole cream, usp

1 % clotrimazole cream, usp
SPL v5
SPL
SPL Set ID b4c4240f-f84c-ec5e-e053-2a95a90aa082
Route
topical
Published
Effective Date 2020-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1 g)
Inactive Ingredients
propylparaben water white petrolatum polyoxyl 20 cetostearyl ether mineral oil cetostearyl alcohol methylparaben propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-11-25 Until 2021-06-14

Purpose

Antifungal

Description

Drug Facts


Medication Information

Warnings

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 2 weeks when used for the treatment of jock itch.
  • there is no improvement within 4 weeks when used for athlete's foot or ringworm.

Uses

  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet.

Purpose

Antifungal

Dosage and Administration
  • For athletes 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.
Directions
  • Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 daily.
Other Information
  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
  • Store at room temperature
  • Preserve in tight containers
  • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients

Inactive Ingredients: Cetostearyl Alcohol, Methylparaben, Mineral Oil, Polyoxyl 20 Cetostearyl Ether,

Propylene Glycol, Propylparaben, Purified water, White petrolatum

Description

Drug Facts

Principal Display Panel

Clotrimazole 1% 1oz 68001-475-47

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited,

Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/739

For BluePoint Laboratories

Rev 09/2021

Section 42229-5

Drug Facts

Section 51945-4

Clotrimazole 1% 0.5oz 68001-475-45

Active Ingredient

Clotrimazole 1 %

Keep Out of Reach of Children

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


Structured Label Content

Warnings

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 2 weeks when used for the treatment of jock itch.
  • there is no improvement within 4 weeks when used for athlete's foot or ringworm.

Uses

  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet.

Purpose

Antifungal

Dosage and Administration (34068-7)
  • For athletes 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.
Directions
  • Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 daily.
Other Information
  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
  • Store at room temperature
  • Preserve in tight containers
  • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive Ingredients: Cetostearyl Alcohol, Methylparaben, Mineral Oil, Polyoxyl 20 Cetostearyl Ether,

Propylene Glycol, Propylparaben, Purified water, White petrolatum

Principal Display Panel

Clotrimazole 1% 1oz 68001-475-47

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited,

Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/739

For BluePoint Laboratories

Rev 09/2021

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Clotrimazole 1% 0.5oz 68001-475-45

Active Ingredient (Active ingredient)

Clotrimazole 1 %

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

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