BOA VIDA ANTIFUNGAL - miconazole nitrate cream 
Central Solutions Inc

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 Ingredients

Miconazole Nitrate 2%

Purpose

Skin protectant

Uses

Treats most jock itch, ringworm and athlete's foot

Warnings

For external use only.

Do not use on children under 2 years of age for diaper rash.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If irritation occurs or if there is no improvement withing 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch, discontinue use and consult a doctor.

Directions

Cleanse the affected area and dry thoroughly.

Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician. Supervise children in the use of this product.

Athlete's foot

Pay special attention to the spaces between toes

wear well-fitting, ventilated shoes and change shoes and socks at least once daily

Athlete's foot and ringworm

use daily for 4 weeks

Jock Itch

use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp or nails.


Other Information

Store at 59-86 F (15-30 C)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cyclopentasiloxane, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Isopropyl Palmitate, Polyquaternium-37, Propylene Glycol Dicaprylate Dicaprate, PPG-1 Trideceth-6, Propylene Glycol, Purified Water, Triethanolamine

BOA

VIDA

Antifungal

Cream

Relieves itching and

burning discomfort associated

with most jock itch, ringworm,

and athlete's foot

4 oz. (113g)

container label

BOA VIDA ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-147
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62654-147-01113 g in 1 TUBE; Type 0: Not a Combination Product09/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/10/2018
Labeler - Central Solutions Inc (007118524)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions Inc007118524manufacture(62654-147)

Revised: 10/2018
Document Id: f119a53c-d97d-4a9a-9e31-e4e47283432f
Set id: 69c5340d-9abd-43bf-a90b-9568d615f06f
Version: 2
Effective Time: 20181018
 
Central Solutions Inc