FDA Label for Critic Aid Skin

View Indications, Usage & Precautions

Critic Aid Skin Product Label

The following document was submitted to the FDA by the labeler of this product Coloplast Manufacturing Us, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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


Active Ingredients



Zinc Oxide: 20%


Purpose



Skin Protectant


Uses



  • Helps protect minor skin irritation due to diaper rash
  • Protects chafed skin due to diaper rash
  • Helps seal out wetness

Warnings



For external use only.


Otc - When Using



When using this product:

  • avoid contact with eyes

Otc - Ask Doctor



Consult a doctor:

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

Otc - Do Not Use



Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Keep Out Of Reach Of Children



Keep 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
  • 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 Ingredients



Cellulose Gum (CMC), Dimethicone, Petrolatum


Questions Or Comments?



Call toll free 1-800-533-0464


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)


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