Anti-fungal Powder Talc

Anti-fungal Powder Talc
SPL v4
SPL
SPL Set ID e69c8d1a-cf46-d3e1-e053-2995a90aaa75
Route
TOPICAL
Published
Effective Date 2019-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Silicon Dioxide Talc

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-19

Description

Miconazole nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate 2%

Uses

fFor 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

Warnings

For external use only.

Directions
  • clean the affected area & dry thoroughly
  • apply a thin layer of the product 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, & change shoes & socks at least once daily
  • for athlete's foot & 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

Other Information
  • Store at room temperature
Active Ingredients

Miconazole nitrate 2%

Inactive Ingredients

Colloidal Anhyhdrous Silica, Talcum Powder

Pincipal Display Panel

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

Keep Out of Reach of Children.

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


Structured Label Content

Uses

fFor 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

Warnings

For external use only.

Directions
  • clean the affected area & dry thoroughly
  • apply a thin layer of the product 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, & change shoes & socks at least once daily
  • for athlete's foot & 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

Other Information (Other information)
  • Store at room temperature
Active Ingredients

Miconazole nitrate 2%

Inactive Ingredients (Inactive ingredients)

Colloidal Anhyhdrous Silica, Talcum Powder

Pincipal Display Panel

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

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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