WELMEDIX HOMECARE PRO 2-IN-1 ANTIFUNGAL AND SKIN PROTECTANT- miconazole nitrate ointment 
Welmedix 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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Welmedix™ HomeCare PRO 2-in-1 Antifungal & Skin Protectant

Active ingredients

Miconazole Nitrate

Purpose

2% Antifungal

Uses

Cures most fungal infections.
Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort associated with fungal infections.

Warnings

For external use only.

When using this product

avoid contact with eyes.
do not use on children under 2 years of age unless directed by a doctor.
Stop using this product and ask a doctor if irritation occurs or there is no improvement within 2 weeks

Keep out of reach of children

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

Directions:

Clean the affected area and dry thoroughly. Apply ointment liberally over affected area twice daily (morning and night) or as directed by a doctor. Use daily for 2 weeks. If condition persists longer, consult a doctor.

Other Information:

Store at 15°C - 30°C (59°F - 86°F).

Inactive ingredients

Aloe Barbadensis Leaf Extract, Calendula Oil, Glycine Soja (Soybean) Oil, Mineral Oil, Petrolatum.

Principal Display Panel

Hospital Grade

New!

Welmedix™ HomeCare PRO

2-in-1 Antifungal & Skin Protectant

Immediately relieves itching & discomfort

Cures most superficial fungal infections

Net Wt. 2.5 oz. (70.8g)

Questions or Comments?
1-888-565-2876
Monday through Friday, 9am - 5 pm
Visit us @ www.welmedix.com

Do not use if tamper-evident seal under cap is compromised or missing.

Dist. by: Welmedix Consumer Healthcare
103 Carnegie Center
Princeton, NJ 08540

Email: homecarepro@welmedic.com

© 2012 Welmedix LLC.
All Rights Reserved.
Made in the USA

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Label and Drug Facts

Label and Drug Facts

WELMEDIX HOMECARE PRO 2-IN-1 ANTIFUNGAL AND SKIN PROTECTANT 
miconazole nitrate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24330-411
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)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
SOY STEROL (UNII: PL360EPO9J)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24330-411-0871 g in 1 TUBE; Type 0: Not a Combination Product04/01/201312/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/01/201312/31/2015
Labeler - Welmedix LLC (830387812)

Revised: 8/2016
 
Welmedix LLC