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Critic aid clear - Medication Information

Product NDC Code 11701-066
Drug Name

Critic aid clear

Type Brand
Active Ingredients
Petrolatum 710 mg/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 686452,
1053000
Application Number M016
Labeler Name Coloplast Manufacturing US, LLC
Packages
Package NDC Code Description
11701-066-22 4 g in 1 packet (11701-066-22)
11701-066-32 170 g in 1 tube (11701-066-32)
11701-066-33 71 g in 1 tube (11701-066-33)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Petrolatum, 71.5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness.

Purpose

Information about the drug product’s indications for use.
Purpose Diaper Rash Skin Protectant

Spl product data elements

Usually a list of ingredients in a drug product.
Critic Aid Clear Petrolatum PETROLATUM PETROLATUM .ALPHA.-TOCOPHEROL ACETATE, D- DIMETHICONE ZINC OXIDE CROSCARMELLOSE SODIUM

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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)

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
For Minor To Severe Skin Irritation Due To Incontinence Adheres to denuded skin Easy to apply and remove Eliminates moisture Drug Facts Active ingredient Petrolatum, 71.5% Purpose Diaper Rash Skin Protectant Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness. Warnings 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. 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.

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Consult a doctor if condition worsens or does not improve within 7 days.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid contact with eyes not to be applied over deep or puncture wounds or lacerations.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings When using this product avoid contact with eyes not to be applied over deep or puncture wounds or lacerations.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API