Critic-aid

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (710 mg)

Inactive Ingredients

.alpha.-tocopherol Acetate, D- Dimethicone Zinc Oxide Croscarmellose Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2009-06-15

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness.

Dosage and Administration

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.

Description

For Minor To Severe Skin Irritation Due To Incontinence Adheres to denuded skin Easy to apply and remove Eliminates moisture

Section 42229-5

For Minor To Severe

Skin Irritation

Due To Incontinence

Adheres to denuded skin
Easy to apply and remove
Eliminates moisture

Section 50565-1

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.

Section 50567-7

When using this product

avoid contact with eyes
not to be applied over deep or puncture wounds or lacerations.

Section 51727-6

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

Section 51945-4

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)

Section 55105-1

Purpose

Diaper Rash Skin Protectant

Section 55106-9

Active ingredient

Petrolatum, 71.5%

Consult A Doctor

if condition worsens or does not improve within 7 days.

Structured Label Content

Indications and Usage (34067-9)

Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

For Minor To Severe

Skin Irritation

Due To Incontinence

Adheres to denuded skin
Easy to apply and remove
Eliminates moisture

Section 50565-1 (50565-1)

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.

Section 50567-7 (50567-7)

When using this product

avoid contact with eyes
not to be applied over deep or puncture wounds or lacerations.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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)

Section 55105-1 (55105-1)

Purpose

Diaper Rash Skin Protectant

Section 55106-9 (55106-9)

Active ingredient

Petrolatum, 71.5%

Consult A Doctor (Consult a doctor)

if condition worsens or does not improve within 7 days.

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "710", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, D-", "unii": "A7E6112E4N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness.", "34068-7": "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.", "34071-1": "Warnings", "42229-5": "For Minor To Severe Skin Irritation Due To Incontinence Adheres to denuded skin Easy to apply and remove Eliminates moisture", "50565-1": "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.", "50567-7": "When using this product avoid contact with eyes not to be applied over deep or puncture wounds or lacerations.", "51727-6": "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", "51945-4": "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)", "55105-1": "Purpose Diaper Rash Skin Protectant", "55106-9": "Active ingredient Petrolatum, 71.5%", "Consult a doctor": "if condition worsens or does not improve within 7 days."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information