ALOE VESTA CLEAR ANTIFUNGAL 56G- miconazole nitrate ointment 
Guest Packaging LLC.

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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Aloe Vesta TM Clear Antifungal Ointment 56g

Drug Facts

Uses

Warnings

For external use only.

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

When using this product, avoid contact with eyes. If irritation occurs or if there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm, discontinue use and consult a physician.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the affected area and dry thoroughly.

For athlete's foot: Pay close 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

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Inactive ingredients

Aloe Barbadensis Leaf Extract, Bis-Diglyceryl Polyacladipate-2, Mineral Oil, Petrolatum

Store at 15°C -30°C (59°F - 86°F)

CLEAR ANTIFUNGAL OINTMENT

    -Athlete's Foot
    -Ringworm
    -Jock Itch
    -Superficial Yeast Infections

with 2 %  Miconazole Nitrate and a Natural Botanical

Manufactured for:
ConvaTec

ConvaTec Inc.
Greensboro, NC 27409
1-800-422-8811
www.convatec.com

Made in USA

Packaging

image description

ALOE VESTA CLEAR ANTIFUNGAL 56G 
miconazole nitrate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11099-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE1.12 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11099-0003-256 g in 1 TUBE; Type 0: Not a Combination Product06/09/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/09/2016
Labeler - Guest Packaging LLC. (001773076)
Establishment
NameAddressID/FEIBusiness Operations
Guest Packaging LLC.001773076manufacture(11099-0003)

Revised: 6/2016
Document Id: ab0fbab0-e4fb-4901-9d65-3e9a2abf07ef
Set id: db904fba-fb27-4371-aa84-3a9553cd89ab
Version: 1
Effective Time: 20160618
 
Guest Packaging LLC.