Critic Aid Clear Af (Miconazole Nitrate) Ointment [Coloplast Manufacturing Us, Llc] -

CRITIC AID CLEAR AF (MICONAZOLE NITRATE) OINTMENT [COLOPLAST MANUFACTURING US, LLC]
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NDC	11701-067-14, 11701-067-22, 11701-067-23
Set ID	cbc5d976-850a-476e-b179-b7a5a8675524
Category	HUMAN OTC DRUG LABEL
Packager	Coloplast Manufacturing US, LLC
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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SPL UNCLASSIFIED SECTION
For Perineal
Skin Irritation Due To
Fungal Infection
- Adheres to denuded skin
- Easy to apply and remove
- Treats topical fungal infections
SPL UNCLASSIFIED SECTION
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

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

Coloplast

NET WT. 5 OZ. (142 g)

INGREDIENTS AND APPEARANCE

CRITIC AID CLEAR AF
miconazole nitrate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11701-067
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
DIMETHICONE (UNII: 92RU3N3Y1O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11701-067-22	4 g in 1 PACKET; Type 0: Not a Combination Product	06/15/2009
2	NDC:11701-067-23	57 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009
3	NDC:11701-067-14	142 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009