antifungal body powder

antifungal body powder
SPL v6
SPL
SPL Set ID 31096041-28c9-4b16-bbd1-dbadefd37505
Route
topical
Published
Effective Date 2011-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (20 mg)
Inactive Ingredients
tricalcium phosphate octenylsuccinic acid carthamus tinctorius seed oleosomes cellulose acetate glycerin hydrated silica sodium bicarbonate kukui nut oil aloe vera leaf maltodextrin niacinamide pyridoxine hydrochloride sodium ascorbyl phosphate .alpha.-tocopherol acetate, dl- levomenol hyaluronate sodium starch, corn ginger oil calcium pantothenate microcrystalline cellulose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2011-09-01

Purpose

Antifungal

Description

Miconazole Nitrate 2.0%


Medication Information

Warnings

For external use only



Uses
  • for the treatment of 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
Purpose

Antifungal

Directions
  • Clean the affected area and 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, 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
Other Information
  • Protect from freezing. Avoid excessive heat.
Inactive Ingredients

Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf

Extract, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes,

Fragrance, Glycerin, Hydrated Silica, Maltodextrin, Microcrystalline Cellulose, Niacinamide (Vitamin

B3), Pyridoxine HCL (Vitamin B6), Sodium Ascorbyl Phosphate (Vitamin C), Sodium Bicarbonate,

Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Tricalcium

Phosphate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract

Description

Miconazole Nitrate 2.0%

Principal Display Panel

NDC 68599-0207-3

Thera

Antifungal Body Powder

Helps treat the most common fungal

infections including athlete's foot,

jock itch and ringworm.

Single Patient Use

Net Weight

3 oz (85 g)

MFR# 53-AFP3

Do Not Use On
  • children under 2 years of age unless directed by a doctor
Active Ingredient

Miconazole Nitrate 2.0%

When Using This Product
  • avoid contact with eyes
Stop Use and Ask A Doctor If
  • for athlete's foot and ringworm - irritation occurs or if there is no improvement within 4 weeks
  • for jock itch - irritation occurs or if there is no improvement within 2 weeks.

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



Uses
  • for the treatment of 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
Purpose

Antifungal

Directions
  • Clean the affected area and 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, 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
Other Information (Other information)
  • Protect from freezing. Avoid excessive heat.
Inactive Ingredients (Inactive ingredients)

Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf

Extract, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes,

Fragrance, Glycerin, Hydrated Silica, Maltodextrin, Microcrystalline Cellulose, Niacinamide (Vitamin

B3), Pyridoxine HCL (Vitamin B6), Sodium Ascorbyl Phosphate (Vitamin C), Sodium Bicarbonate,

Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Tricalcium

Phosphate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract

Principal Display Panel

NDC 68599-0207-3

Thera

Antifungal Body Powder

Helps treat the most common fungal

infections including athlete's foot,

jock itch and ringworm.

Single Patient Use

Net Weight

3 oz (85 g)

MFR# 53-AFP3

Do Not Use On (Do not use on)
  • children under 2 years of age unless directed by a doctor
Active Ingredient (Active ingredient)

Miconazole Nitrate 2.0%

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)
  • for athlete's foot and ringworm - irritation occurs or if there is no improvement within 4 weeks
  • for jock itch - irritation occurs or if there is no improvement within 2 weeks.

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.


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