Cr-1232

Cr-1232
SPL v10
SPL
SPL Set ID 776ca76a-a6cc-5238-e053-2a91aa0abfcb
Route
TOPICAL
Published
Effective Date 2018-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Petrolatum Sodium Phosphate Dibasic Dihydrate Sodium Phosphate, Monobasic, Dihydrate Edetate Disodium Anhydrous Ceteareth-12 Cetostearyl Alcohol Chlorocresol Light Mineral Oil Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-30

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

Uses
  • For the treatment of most athlete's foot, tinea pedis, jock itch, tinea crusis, ringworm, tinea corporis
  • Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet
Label

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Warnings

For external use only

Questions

1-888-DYNAREX

Directions
  • Clean the 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 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, consult a doctor
  • This product is not effective on the scalp or nails
Do Not Use
  • on children under 2 years of age unless directed by a doctor
  • for diaper rash
Active Ingredient

Miconazole Nitrate 2%

Other Information

Store at 15° -30°C (59° -86°F)

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Disodium Hydrogen Phosphate Dihydrate, Light Liquid Paraffin, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Dihydrogen Phosphate Dihydrate, White Soft Paraffin

When Using This Product

avoid contact with the 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

Structured Label Content

Uses
  • For the treatment of most athlete's foot, tinea pedis, jock itch, tinea crusis, ringworm, tinea corporis
  • Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet
Label

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Purpose

Antifungal

Warnings

For external use only

Questions

1-888-DYNAREX

Directions
  • Clean the 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 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, 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 unless directed by a doctor
  • for diaper rash
Active Ingredient

Miconazole Nitrate 2%

Other Information

Store at 15° -30°C (59° -86°F)

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Disodium Hydrogen Phosphate Dihydrate, Light Liquid Paraffin, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Dihydrogen Phosphate Dihydrate, White Soft Paraffin

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)