THERA ANTIFUNGAL BODY- miconazole nitrate powder 
McKesson Medical-Surgical Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antifungal Body Powder

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

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

Other information

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

53-AFP3 each

THERA ANTIFUNGAL BODY 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0207
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-0207-385 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/01/2011
Labeler - McKesson Medical-Surgical Inc. (023904428)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions007118524manufacture(68599-0207)

Revised: 1/2021
Document Id: b8e1f33c-9d43-0ded-e053-2995a90abf98
Set id: 31096041-28c9-4b16-bbd1-dbadefd37505
Version: 5
Effective Time: 20210114
 
McKesson Medical-Surgical Inc.