CAREALL MICONAZOLE NITRATE- miconazole nitrate cream

CAREALL Miconazole Nitrate by

Drug Labeling and Warnings

CAREALL Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

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 (1-800-222-1222).

Uses

• Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
• For effective relief of itching, scaling, burning and discomfort

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoide contact with eyes

Stop use and ask doctor if

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

Directions

• wash affected area and dry thoroughly
• apply a thin layer of the product 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 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, consult a doctor
• not effective on the scalp or nails

Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-078
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 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-078-01	28 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	12/01/2020

Labeler - New World Imports, Inc (075372276)