FDA.reportPublic FDA data

Critic-Aid Clear - Coloplast Corp | Coloplast Corp. | Medline Industries, LP

Manufacturer
Coloplast Corp | Coloplast Corp. | Medline Industries, LP
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:52:22

Label at a glance#

ProductCritic-Aid Clear
Active ingredientPETROLATUM
Label structure9 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum, 86.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • Do not get into eyes.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2677087Critic-Aid Clear Moisture 86.5 % Topical OintmentPSN5
2383008petrolatum 86.5 % Topical OintmentPSN5
2677087petrolatum 0.865 MG/MG Topical Ointment [Critic-Aid Clear Moisture]SBD5
2383008petrolatum 0.865 MG/MG Topical OintmentSCD5
2677087Critic-Aid Clear Moisture 0.865 MG/MG Topical OintmentSY5
2677087Critic-Aid Clear Moisture 86.5 % Topical OintmentSY5
2383008petrolatum 86.5 % Topical OintmentSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11701-083-222024-12-26C16284748780-1f386c64a-46dd-0266-e053-dadaa90a7c1aCritic-Aid ® Clear
11701-083-322024-12-26C16284748780-1f386c64a-46dd-0266-e053-dadaa90a7c1aCritic-Aid ® Clear
11701-083-332024-12-26C16284748780-1f386c64a-46dd-0266-e053-dadaa90a7c1aCritic-Aid ® Clear
11701-083-222023-01-30C16284748780-1f386c64a-46dd-0266-e053-dadaa90a7c1aCritic-Aid ® Clear
11701-083-322023-01-30C16284748780-1f386c64a-46dd-0266-e053-dadaa90a7c1aCritic-Aid ® Clear
11701-083-332023-01-30C16284748780-1f386c64a-46dd-0266-e053-dadaa90a7c1aCritic-Aid ® Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-083-22Critic-Aid Clear4 g in 1 PACKETOINTMENT45
11701-083-32Critic-Aid Clear170 g in 1 TUBEOINTMENT1705
11701-083-33Critic-Aid Clear71 g in 1 TUBEOINTMENT715

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-083-33GM - Gram11701-0832b246944-ea43-4354-8a56-51a9874fb53212022-11-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11701-08311701-083-22, 11701-083-33, 11701-083-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
ZINC OXIDESOI2LOH54ZIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
DIMETHICONE 1000MCU2324216IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Critic-Aid ClearPETROLATUMColoplast Corpa92c18f7-52b2-43e4-bae3-2bab9de226712026-03-31WarningsExact identifier
ndc (package): 11701-083-33
ndc (package): 11701-083-32
ndc (package): 11701-083-22
ndc (product): 11701-083
ndc11 (package): 11701008322
ndc11 (package): 11701008333
ndc11 (package): 11701008332
spl id: 9261d551-442d-41a0-89e6-a52106e5d407
spl set id: a92c18f7-52b2-43e4-bae3-2bab9de22671

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.