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| Product NDC Code | 11701-050 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Critic aid skin |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PASTE | ||||||
| RxCUI drug identifier | 416684, 1486031 |
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| Application Number | M015 | ||||||
| Labeler Name | Coloplast Manufacturing US, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Zinc Oxide: 20%
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 Clean the affected area and dry thoroughly Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a doctor. Change wet and soiled absorbent brief/diapers promptly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Cellulose Gum (CMC), Dimethicone, Petrolatum
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 protect minor skin irritation due to diaper rash Protects chafed skin due to diaper rash Helps seal out wetness
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Critic Aid Skin Zinc oxide ZINC OXIDE ZINC OXIDE PETROLATUM DIMETHICONE 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 - 170 g Tube Label NDC 11701-050-32 Critic-Aid ® Skin Paste Skin Protectant Thick Moisture Barrier Paste For Minor to Severe Skin Irritation Due to Incontinence Product #1947 Coloplast NET WT. 6 OZ. (170 g) Principal Display Panel - 170 g Tube Label
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.Drug Facts
Manufactured by: Coloplast A/S Holtedam 1, DK-3050 Humlebaek, Denmark Distributed by: Coloplast Corp 1601 W River Rd. N, Minneapolis, MN 55411 USA
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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on: deep or puncture wounds animal bites serious burns
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.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll free 1-800-533-0464
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
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 For external use only. When using this product: avoid contact with eyes Consult a doctor: if condition worsens or does not improve within 7 days. Do not use on: deep or puncture wounds animal bites serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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