MAKESENSE - miconazole cream 
Cherry Hill Sales Co

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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Drug Facts

Active Ingredient

Miconazole 2.0%

Purpose

Antifungal

Uses

■ Cures most athlete's foot, jock itch, and ringworm

■ relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only.

Do not use

■ on children under 2 years of age except under the advise and supervision of a doctor ■ for diaper rash

When using this product

■ avoid contact with eyes

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 (jock itch)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

■ wash affected area and dry thoroughly ■ apply a thin layer 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 a day ■ for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks ■ if conditions persist longer, ask a doctor ■ this product is not effective on the scalp or nails.

Other Information

■  store at 59 to 86F (15 to 30C)

Inactive Ingredients

Cetearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Stearate

Package Label

image description

MAKESENSE 
miconazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-208
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69020-208-2828 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/15/2014
Labeler - Cherry Hill Sales Co (145959768)

Revised: 7/2014
Document Id: cd1f86f8-255a-480e-bc47-1cb177465eb8
Set id: 99a36af9-ec04-48fd-a7b7-73d870c087bb
Version: 1
Effective Time: 20140731
 
Cherry Hill Sales Co