Critic-aid Clear Ointment
FDA Label NDC 11701-083

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 11701-083). 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, active ingredient, purpose, uses, warnings, otc - when using, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Manufactured by: Coloplast Corp., 1940 Commerce Drive,
North Mankato, MN 56003

Distributed by: Coloplast Corp. 1601 West River Road,
Minneapolis, MN 55411, U.S.A.

Active Ingredient

Petrolatum, 86.5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin. Helps seal out wetness.

Warnings

For external use only.

Otc - When Using

When using this product

  • Do not get into eyes.

Otc - Do Not Use

  • Do not use on:
    • deep or puncture wounds
    • animal bites
    • serious burns.

Otc - Ask Doctor

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the affected area and dry thoroughly.
  • Knead before use.
  • Apply a thin layer liberally enough to cover yet visualize the skin.
  • Apply to the affected area twice daily (morning and night), or as directed by a doctor.
  • Supervise children in the use of this product.

Inactive Ingredients

cellulose gum (CMC), dimethicone, tocopheryl acetate, zinc oxide

Principal Display Panel - 170 G Tube Label

NDC 11701-083-32

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 (170 g Tube Label)

Principal Display Panel (170 g Tube Label)

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