Critic Aid Clear Ointment
FDA Label NDC 11701-066

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coloplast Corp for the product Critic Aid Clear (NDC 11701-066). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, consult a doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

For Minor To Severe
Skin Irritation
Due To Incontinence

  • Adheres to denuded skin
  • Easy to apply and remove
  • Eliminates moisture

    • Drug Facts

Otc - Active Ingredient

Active ingredient

Petrolatum, 71.5%

Otc - Purpose

Purpose

Diaper Rash Skin Protectant

Indications & Usage

Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness.

Warnings

Warnings

Otc - When Using

When using this product

  • avoid contact with eyes
  • not to be applied over deep or puncture wounds or lacerations.

Consult A Doctor

  • if condition worsens or does not improve within 7 days.

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

  • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Inactive Ingredient

Inactive ingredients

cellulose gum, dimethicone, tocopheryl acetate, zinc oxide

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 #7567
©2007, Coloplast Corp. Made in the U.S.A.

E10-1347

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL - NET WT. 6 OZ. (170 g)

NDC 11701-066-32

Critic-Aid®Clear

Skin Protectant

Clear Moisture Barrier Ointment

For Minor To Severe

Skin Irritation

Due To Incontinence

Coloplast

NET WT. 6 OZ. (170 g)

Principal Display Panel (NET WT. 6 OZ. (170 g))

Principal Display Panel (NET WT. 6 OZ. (170 g))

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