FDA Label for Critic Aid Clear Af

View Indications, Usage & Precautions

Critic Aid Clear Af Product Label

The following document was submitted to the FDA by the labeler of this product Coloplast Manufacturing Us, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



For Perineal
Skin Irritation Due To
Fungal Infection

  • Adheres to denuded skin
  • Easy to apply and remove
  • Treats topical fungal infections
  • Drug Facts


Otc - Active Ingredient



Active ingredient

Miconazole nitrate, 2%


Otc - Purpose



Purpose

Antifungal


Indications & Usage



Uses For effective treatment of jock itch. Relieves itching, scaling, irritation, redness and discomfort.


Warnings



Warnings


Otc - When Using



When using this product

  • avoid contact with eyes
  • do not use on children under 2 years of age unless directed by a doctor

Otc - Stop Use



Stop using this product and ask a doctor if irritation occurs or there is no improvement within 2 weeks.


Otc - Keep Out Of Reach Of Children



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.


Dosage & Administration



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 Ingredient



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


Package Label.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)


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