CRITIC AID CLEAR AF- miconazole nitrate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)

Available from:

Coloplast Manufacturing US, LLC

INN (International Name):

MICONAZOLE NITRATE

Composition:

MICONAZOLE NITRATE 20 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

CRITIC AID CLEAR AF- MICONAZOLE NITRATE OINTMENT
COLOPLAST MANUFACTURING US, 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._
----------
_CRITIC-AID_
_CLEAR AF_
ANTIFUNGAL OINTMENT
CLEAR MOISTURE BARRIER WITH ANTIFUNGAL
For Perineal
Skin Irritation Due To
Fungal Infection
Adheres to denuded skin
Easy to apply and remove
Treats topical fungal infections
_DRUG FACTS_
_ACTIVE INGREDIENT_
Miconazole nitrate, 2%
_PURPOSE_
Antifungal
_USES_ For effective treatment of jock itch. Relieves itching,
scaling, irritation, redness and discomfort.
_WARNINGS_
_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.
FOR EXTERNAL USE ONLY. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF
CHILDREN. If swallowed, get
medical help or contact a Poison Control Center right away.
_DIRECTIONS_
clean the affected area and dry thoroughly
apply thin layer of product over affected area twice daily (morning
and night), or as directed by a
doctor
supervise children in the use of this product.
Use daily for 2 weeks.
If condition persists, consult a doctor. This product is not effective
on scalp or nails.
_INACTIVE INGREDIENTS_
cellulose gum, dimethicone, petrolatum, tocopheryl acetate
Patent Pending
See crimp for lot no. and expiration date
Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.
®
1-800-533-0464 www.us.coloplast.com PRODUCT # 7572
©2007, Coloplast Corp. Made in the U.S.A.
L7-1349
_PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)_
NDC 11701-067-14
_Critic-Aid_
_Clear AF_
Antifungal Ointment
Clear Moisture Barrier With Antifungal
For Perineal
Skin Irritation Due To
Fungal Infection
COLOPLAS T
NET WT. 5 OZ. (142 g)
®
CRITIC AID CLEAR AF
miconazo