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.

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Critic-Aid®Clear AF
Antifungal Ointment
Clear Moisture Barrier With Antifungal

For Perineal
Skin Irritation Due To
Fungal Infection

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

Coloplast

NET WT. 5 OZ. (142 g)

PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)
CRITIC AID CLEAR AF 
miconazole nitrate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11701-067-224 g in 1 PACKET; Type 0: Not a Combination Product06/15/2009
2NDC:11701-067-2357 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
3NDC:11701-067-14142 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/15/2009
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIBusiness Operations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-067)

Revised: 2/2018
Document Id: 2ea35359-ddf6-4086-94c6-9a6bc2311f32
Set id: cbc5d976-850a-476e-b179-b7a5a8675524
Version: 8
Effective Time: 20180216
 
Coloplast Manufacturing US, LLC