Critic-Aid ® Clear Skin ProtectantClear Moisture Barrier Ointment

CRITIC AID CLEAR - petrolatum ointment
Coloplast Manufacturing US, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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For Minor To Severe
Skin Irritation
Due To Incontinence

Adheres to denuded skin
Easy to apply and remove
Eliminates moisture

Drug Facts

Active ingredient

Petrolatum, 71.5%

Purpose

Diaper Rash Skin Protectant

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

Warnings

When using this product

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

Consult a doctor

if condition worsens or does not improve within 7 days.

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.

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.

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

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)

CRITIC AID CLEAR
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11701-066
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (PETROLATUM)	PETROLATUM	710 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, D-
DIMETHICONE
ZINC OXIDE
CROSCARMELLOSE SODIUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:11701-066-22	4 g in 1 PACKET	None
2	NDC:11701-066-33	71 g in 1 TUBE	None
3	NDC:11701-066-32	170 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE

Revised: 06/2011 Coloplast Manufacturing US, LLC