Critic-aid

Critic-aid
SPL v9
SPL
SPL Set ID cbc5d976-850a-476e-b179-b7a5a8675524
Route
TOPICAL
Published
Effective Date 2024-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Petrolatum .alpha.-tocopherol Acetate, D- Dimethicone Croscarmellose Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-06-15

Description

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


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and 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.

Description

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

Section 42229-5

For Perineal

Skin Irritation Due To

Fungal Infection

  • Adheres to denuded skin
  • Easy to apply and remove
  • Treats topical fungal infections
Section 50565-1

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.

Section 50566-9

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

Section 50567-7

When using this product

  • avoid contact with eyes
  • do not use on children under 2 years of age unless directed by a doctor
Section 51727-6

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

Section 51945-4

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)

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

Miconazole nitrate, 2%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

For Perineal

Skin Irritation Due To

Fungal Infection

  • Adheres to denuded skin
  • Easy to apply and remove
  • Treats topical fungal infections
Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
  • do not use on children under 2 years of age unless directed by a doctor
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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)

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Miconazole nitrate, 2%


Advanced Ingredient Data


Raw Label Data

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