Atopalm Clotrimazole Antifungal Cream

Atopalm Clotrimazole Antifungal Cream
SPL v4
SPL
SPL Set ID 961de13a-b052-4903-b55e-a6b146f60af1
Route
TOPICAL
Published
Effective Date 2015-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Water Glycerin Cetyl Alcohol Mineral Oil Glyceryl Monostearate Stearic Acid Carbomer Homopolymer Type C Cholesterol Myristoyl/palmitoyl Oxostearamide/arachamide Mea Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-03-16

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 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 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 not effective on the scalp or nails

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other Information

  • store at 20 degrees to 25 degrees  (68 degrees to 77 degrees F)
  • see end of carton or tube crimp for lot number and expiration date

Section 50565-1

Keep out of reach of children to avoid accidental ingestion. 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 ring worm) 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 diaper rash or on children under 2 years of age unless directed by a doctor.



Section 51727-6

Inactive Ingredients

Water, Glycerin,Cetyl Alcohol, Mineral Oil, Glyceryl Stearate, PEG Glyceryl Stearate, Stearic Acid, Benzyl Alcohol, Carbomer 940, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Triethanolamine

Section 53413-1

Questions? Call 1-855-ATOPALM

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active Ingredients

Clotrimazole 1%

Product Labeling




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 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 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 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 20 degrees to 25 degrees  (68 degrees to 77 degrees F)
  • see end of carton or tube crimp for lot number and expiration date

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental ingestion. 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 ring worm) 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 diaper rash or on children under 2 years of age unless directed by a doctor.



Section 51727-6 (51727-6)

Inactive Ingredients

Water, Glycerin,Cetyl Alcohol, Mineral Oil, Glyceryl Stearate, PEG Glyceryl Stearate, Stearic Acid, Benzyl Alcohol, Carbomer 940, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Triethanolamine

Section 53413-1 (53413-1)

Questions? Call 1-855-ATOPALM

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active Ingredients

Clotrimazole 1%

Product Labeling




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)