Family Wellness Clotrimazole 1% Anti Fungal Cream

Family Wellness Clotrimazole 1% Anti Fungal Cream
SPL v2
SPL
SPL Set ID 0667dd81-5633-494e-857e-45fa276fe72c
Route
TOPICAL
Published
Effective Date 2023-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Cetostearyl Alcohol Ethylparaben Glycerin Glyceryl Monostearate Mineral Oil Petrolatum Water Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Clotrimazole 1% w/w

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1% w/w

Uses
  • cures most athlete’s foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which can accompany these conditions.
Warnings

For external use only.

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, 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 conditions persists longer, consult a doctor.
  • this product is not effective on the scalp or nails.
Do Not Use
  • on children under 2 years of age except under the advice of a doctor.
Active Ingredient

Clotrimazole 1% w/w

Package Labeling:

Other Info Rmation
  • store at room temperature 20°-25°C (68°-77°F).
  • close cap tightly after use.
Inactive Ingredients

cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, mineral oil, peregal O-25, petrolatum, purified water, stearic acid

Questions Or Comments?

Call 1-800-639-3803Weekdays 9 AM to 4 PM EST

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 within 2 weeks (for jock itch).
If Pregnant Or Breast Feeding,

ask a health professional before use

Keep This and All Drugs Out of the Reach of Children.

if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Uses
  • cures most athlete’s foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which can accompany these conditions.
Purpose

Antifungal

Warnings

For external use only.

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, 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 conditions persists longer, consult a doctor.
  • this product is not effective on the scalp or nails.
Do Not Use (Do not use)
  • on children under 2 years of age except under the advice of a doctor.
Active Ingredient (Active ingredient)

Clotrimazole 1% w/w

Package Labeling:

Other Info Rmation (Other info rmation)
  • store at room temperature 20°-25°C (68°-77°F).
  • close cap tightly after use.
Inactive Ingredients (Inactive ingredients)

cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, mineral oil, peregal O-25, petrolatum, purified water, stearic acid

Questions Or Comments? (Questions or comments?)

Call 1-800-639-3803Weekdays 9 AM to 4 PM EST

When Using This Product (When using this product)
  • avoid contact with eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs.
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch).
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)

if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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