SOOTHE AND COOL TREAT- miconazole nitrate cream

Soothe And Cool Treat by

Drug Labeling and Warnings

Soothe And Cool Treat 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

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 ■ there is 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, Fragrance, Hydrogenated Castor Oil, Imidazolidinyl Urea, Isopropyl Palmitate, Petrolatum, Polymethoxy Bicyclic Oxazolidine, Sodium Chloride, Water, Zinc Oxide.

SPL UNCLASSIFIED SECTION

www.medline.com

Manufactured in USA for Medline Industries, Inc.,

Mundelein, IL 60060 USA. 1-800-MEDLINE RF15SAP

Principal Display Panel - 5 fl oz

NDC: 53329-080-57

Soothe&Cool

TREAT

INZO Antifungal Cream

• Miconazole Nitrate 2%
• Treats fungal infections
• Aids in maintaining healthy skin

5 ​oz (141.7 mL)

REF MSC095635

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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

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)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(53329-080)