ANTIFUNGAL BODY- miconazole nitrate cream

Antifungal Body by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Miconazole Nitrate 2%

PURPOSE

Purpose

Antifungal

INDICATIONS & USAGE

Uses

• for 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
• for treatment ofsuperficial skin infections caused by yeast (Candida albicans)

WARNINGS

Warnings

• For External use only. ​

​When using this product

• Do not get into eyes

Stop use and ask a doctor if

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

Do not use on

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

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.

DOSAGE & ADMINISTRATION

Directions

• Clean the affected area and dry thoroughly
• Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
• Supervise children in the use of this product

Athlete’s foot

• Pay special attention to the spaces between toes
• Wear well-fitting, ventilated shoes and change shoes and socksat least once daily

Athlete’s foot and ringworm

• Use daily for 4 weeks

Jock itch

• Use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp or nails.

INACTIVE INGREDIENT

Inactive ingredients
Isopropyl Palmitate, Glyceryl Stearate, PEG 100 Stearate, Cyclopentasiloxane, Cetearyl Alcohol, Propylene Glycol, Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf Juice, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopherol Acetate (Vitamin E), Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Triethanolamine, DMDM Hydantoin, Iodopropynyl Butylcarbamate

PRINCIPAL DISPLAY PANEL

McKesson Thera Antifungal Body Cream

Helps treat the most common fungal infections including athlete's foot, jock itch and ringworm.

Single Patient Use

Therapy [for the skin]

Net Contents 4 fl oz (118ml)

MFR# 53-AF4

INGREDIENTS AND APPEARANCE

ANTIFUNGAL BODY 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
ALOE (UNII: V5VD430YW9)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
NIACINAMIDE (UNII: 25X51I8RD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LYSINE (UNII: K3Z4F929H6)
ARGININE (UNII: 94ZLA3W45F)
THREONINE (UNII: 2ZD004190S)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCINE (UNII: TE7660XO1C)
.BETA.-ALANINE (UNII: 11P2JDE17B)
VALINE (UNII: HG18B9YRS7)
METHIONINE (UNII: AE28F7PNPL)
ISOLEUCINE (UNII: 04Y7590D77)
PHENYLALANINE (UNII: 47E5O17Y3R)
CYSTEINE (UNII: K848JZ4886)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALCOHOL (UNII: 3K9958V90M)
LEUCINE (UNII: GMW67QNF9C)
TYROSINE (UNII: 42HK56048U)
TROLAMINE (UNII: 9O3K93S3TK)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ASPARTIC ACID (UNII: 30KYC7MIAI)
SERINE (UNII: 452VLY9402)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
HISTIDINE (UNII: 4QD397987E)
GLUTAMIC ACID (UNII: 3KX376GY7L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEG-100 STEARATE (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0206-4	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/01/2017

Labeler - McKesson (023904428)

Establishment
Name	Address	ID/FEI	Business Operations
Central Solutions		007118524	manufacture(68599-0206)