CRITIC AID SKIN - petrolatum and zinc oxide paste 
Coloplast Manufacturing US, LLC

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Critic-Aid® Skin Paste
Now With CMC
Anorectal Skin Protectant
Thick Moisture Barrier Paste

For Minor to Severe Skin Irritation Due to Incontinence

Drug Facts

Active ingredients

Petrolatum, 51%

Zinc Oxide, 20%

Purpose

Anorectal & Diaper Rash

Skin Protectant

Uses

• Provides temporary relief from skin irritations due to diaper rash, severe or chronic diarrhea, incontinence and enzymatic drainage. Helps seal out wetness.

Warnings

When using this product

• avoid contact with eyes.
• Consult a doctor if condition worsens or does not improve within 7 days or in case of bleeding, consult a physician promptly
• do not put this product into the rectum by using fingers or any mechanical device or applicator.

For external use only.

• Do not exceed the recommended daily dosage unless directed by a doctor.

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

Directions

Adults

• cleanse 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.

Childeren under 12 years of age

• consult a physician.

Inactive ingredients cellulose gum (CMC), dimethicone

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 #1944 ©2009-6, Coloplast Corp.
Made in the U.S.A.

F9-675

PRINCIPAL DISPLAY PANEL - NET WT. 2.5 OZ (71 g)

NDC 11707-050-33

Critic-Aid® Skin Paste

Now With CMC

Anorectal Skin Protectant

Thick Moisture Barrier Paste

For Minor to Severe Skin Irritation Due to Incontinence

Coloplast

NET WT. 2.5 OZ (71 g)

CRITIC AID SKIN   petrolatum and zinc oxide   paste

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 11701-050 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (PETROLATUM) PETROLATUM 510 mg  in 1 g ZINC OXIDE (ZINC) ZINC OXIDE 200 mg  in 1 g

Inactive Ingredients Ingredient Name Strength DIMETHICONE   CROSCARMELLOSE SODIUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11701-050-33 71 g In 1 TUBE None 2 11701-050-32 170 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	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: 06/2010Coloplast Manufacturing US, LLC