Soothe And Cool Treat (Miconazole Nitrate) Cream [Medline Industries, Inc.] -

SOOTHE AND COOL TREAT (MICONAZOLE NITRATE) CREAM [MEDLINE INDUSTRIES, INC.]
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NDC	53329-080-57, 53329-080-58
Set ID	2915e550-a446-66b3-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Medline Industries, LP
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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Active ingredient

Miconazole Nitrate 2%
Purpose

Antifungal
Uses
- 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 most 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 the eyes
Stop use and ask a doctor
- if irritation occurs
- there is no improvement within 4 weeks for athlete's foot and ringworm
- thereis no improvement within 2 weeks for jock itch
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 thin layer over affected area twice daily or as directed by a physician
- supervise use by children
- 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 four weeks
- for jock itch, use daily for two weeks
- if condition persists longer, consult a doctor
- this product is not effective on scalp or nails
Other information
- Protect from freezing. Avoid excessive heat.
Inactive ingredients

allantoin, bees wax, cetyl dimethicone, cetyl PEG/PGG-10/1 dimethicone, dimethicone, fragrance, hydrogenated castor oil, imidazolidinyl urea, isopropyl palmitate, petrolatum, polymethoxy bicyclic oxazolidine, sodium chloride, water, zinc oxide
Manufacturing Information

Manufactured for Medline Industries, Inc.,

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com
1-800-MEDLINE

REF: MSC095635

RA21SAP
Package Label

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL TREAT
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
5-HYDROXYMETHYL(METHYLENEOXY)-1-AZA-3,7-DIOXABICYCLO(3,3,0)OCTANE (UNII: 82EKS47IC5)
ALLANTOIN (UNII: 344S277G0Z)
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
IMIDUREA (UNII: M629807ATL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-080-57	141 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2007
2	NDC:53329-080-58	56 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2007