CRITIC AID CLEAR AF- miconazole nitrate ointment

Critic Aid Clear AF by

Drug Labeling and Warnings

Critic Aid Clear AF by is a Otc medication manufactured, distributed, or labeled by Coloplast Manufacturing US, LLC, Coloplast Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE(11701-067)