CareOne Antifungal Miconazole Jock Itch Powder Spray

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Foodhold USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MICONAZOLE NITRATE- jock itch spray aerosol, spray 
Foodhold USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CareOne Antifungal Miconazole Jock Itch Powder Spray

Active ingredient

Miconazole nitrate 2%

​ ​Purpose

Antifungal

Uses

• cures most jock itch (tinea cruris)

• relieves symptoms of jock itch including itching, burning and chafing associated with jock itch

​Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF.

When using this product

• do not get into eyes or mouth
• use only as directed. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

​Stop use and ask a doctor if

• irritation occurs
• 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. Do not use on children under 2 years of age. Do not use for diaper rash. Do not use on children under 2 years of age unless directed by a doctor.

​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
• use daily for 2 weeks. If conditions persist, consult a doctor
• this product is not effective on scalp or nails
• in case of clogging, clear nozzle under running water

​Other information

store between 20º and 30ºC (68ºF and 86º)

​Inactive ingredient

isobutane (propellent), SD alcohol 40-B (14%w/w), stearalkonium hectorite, talc

​Questions?

Call 1-866-964-0939

Principal Display Panel

CareOne

MEDICATED

Jock Itch Spray

Miconazole Nitrate 2% Antifungal

Antifungal Powder Spray

• For the relief of itching, chafing, scaling & burning
• Cures most jock itch

NET WT 4.6 OZ (130g)

MICONAZOLE NITRATE 
jock itch spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-087
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	1.3 g  in 131 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE (UNII: BXR49TP611)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
ALCOHOL (UNII: 3K9958V90M)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-087-46	131 g in 1 CAN; Type 0: Not a Combination Product	12/19/2017	03/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/19/2017	03/02/2020

Labeler - Foodhold USA (809183973)

Revised: 12/2019

Document Id: 995f715f-fdac-714b-e053-2a95a90a86da

34390-5

Set id: 80e70285-0737-4a66-b1bf-77736e197c6b

Version: 3

Effective Time: 20191210

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