Critic Aid Skin Paste
FDA Label NDC 11701-050

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 Skin (NDC 11701-050). 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 ingredients, purpose, uses, warnings, otc - when using, otc - ask doctor, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Otc - When Using

→ Otc - Ask Doctor

→ Otc - Do Not Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 170 G Tube Label

Other

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.