SIGNATURE CARE ATHLETES FOOT- miconazole nitrate spray

signature care athletes foot by

Drug Labeling and Warnings

signature care athletes foot by is a Otc medication manufactured, distributed, or labeled by Safeway. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• for effective relief of itching, cracking, burning, scaling and discomfort

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

• avoid contact with the eyes
• use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
• contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F (49°C).

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• wash affected area and dry thoroughly
• shake can well and spray a thin layer over affected area twice daily (morning and night)
• 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 shoes and 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, ask a doctor
• this product is not effective on the scalp or nails
• in case of clogging, clean nozzle with a pin

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

alcohol denat., aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

Questions or comments?

1-888-723-3929

Principal Display Panel

Athlete’s Foot Spray

Miconazole Nitrate 2%

Antifungal

POWDER SPRAY

COMPARE TO Lotrimin® AF Antifungal Powder Spray active ingredient

Cures most athlete’s foot

Relieves itching, burning, cracking and scaling

NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

SIGNATURE CARE ATHLETES FOOT 
miconazole nitrate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-341
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
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TALC (UNII: 7SEV7J4R1U)
ALCOHOL (UNII: 3K9958V90M)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)

Product Characteristics
Color	WHITE (to off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-341-90	130 g in 1 CAN; Type 0: Not a Combination Product	10/09/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/09/2015

Labeler - Safeway (009137209)