REMEDY ANTIFUNGAL WITH OLIVAMINE- miconazole nitrate cream

Remedy Antifungal by

Drug Labeling and Warnings

Remedy Antifungal by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Use

• For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• For the treatment of superficial skin infections caused by yeast (Candida albicans)
• 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
• avoid contact with the eyes
• for athlete's foot and ringworm - if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor
• for jock itch - if irritation occurs, or if there is no improvement within 2 weeks, discontinue use and consult a doctor

Keep out of reach of children.

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

Directions

• Clean the affected area and dry thoroughly.
• Apply a layer of cream 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 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

acrylamide/ammonium acrylate copolymer, aloe barbadensis leaf juice, apricot kernel oil peg-6 esters, ascorbic acid, ascorbyl palmitate, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil, citrus tangerina (tangerine) peel oil, diazolidinyl urea, ethyl vanillin, glycine, glycine soja (soybean) oil, glycol stearate, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, peg-6 stearate, peg-8, peg-32 stearate, polyisobutene, polysorbate-20, propanediol, propylene glycol, propylparaben, pyridoxine hcl, retinyl palmitate, silica, tocopherol, triethanolamine, water.

SPL UNCLASSIFIED SECTION

Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured in USA for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA.
www.medline.com 1-800-MEDLINE RJ18WAR

Principal Display Panel - Remedy

INGREDIENTS AND APPEARANCE

REMEDY ANTIFUNGAL  WITH OLIVAMINE
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-162
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
PROPANEDIOL (UNII: 5965N8W85T)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)
CORN OIL (UNII: 8470G57WFM)
TAURINE (UNII: 1EQV5MLY3D)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PEG-6 STEARATE (UNII: 8LQC57C6B0)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
MANDARIN OIL (UNII: NJO720F72R)
HYDROXYTYROSOL (UNII: QEU0NE4O90)
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)
ORANGE OIL (UNII: AKN3KSD11B)
PROLINE (UNII: 9DLQ4CIU6V)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
PEG-32 STEARATE (UNII: 33GX5WQC0M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCINE (UNII: TE7660XO1C)
SOYBEAN OIL (UNII: 241ATL177A)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
GLYCOL STEARATE (UNII: 0324G66D0E)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
NIACINAMIDE (UNII: 25X51I8RD4)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-162-04	113 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2007

Labeler - Medline Industries, Inc. (025460908)