THERA ANTIFUNGAL BODY- miconazole nitrate powder

THERA Antifungal Body by

Drug Labeling and Warnings

THERA Antifungal Body by is a Otc medication manufactured, distributed, or labeled by McKesson Medical-Surgical Inc., Central Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole Nitrate 2.0%

Purpose

Antifungal

Keep out of reach of children.

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

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

Warnings

For external use only

Do not use on

• children under 2 years of age unless directed by a doctor

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.
  

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 Seed Oil, Aloe Barbadensis Juice, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Cellulose, Fragrance, Glycerin, Hydrated Silica, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Sodium Ascorbyl Phosphate (Vitamin C), Sodium Bicarbonate, Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), 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

INGREDIENTS AND APPEARANCE

THERA ANTIFUNGAL BODY 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
NIACINAMIDE (UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LEVOMENOL (UNII: 24WE03BX2T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
STARCH, CORN (UNII: O8232NY3SJ)
GINGER OIL (UNII: SAS9Z1SVUK)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0207-3	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/01/2011

Labeler - McKesson Medical-Surgical Inc. (023904428)