CRITIC AID SKIN- petrolatum and zinc oxide paste 
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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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)

PRINCIPAL DISPLAY PANEL
CRITIC AID SKIN 
petrolatum and zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11701-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM510 mg  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
CROSCARMELLOSE SODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11701-050-3371 g in 1 TUBE
2NDC:11701-050-32170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/15/2009
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIBusiness Operations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-050)

Revised: 6/2012
Document Id: ad2fd2a2-38bf-4152-8aee-5ddce3e82469
Set id: caaac1f0-437d-4185-8670-9f11b9cefe63
Version: 4
Effective Time: 20120630
 
Coloplast Manufacturing US, LLC