CRITIC AID CLEAR- petrolatum ointment

Critic Aid Clear by

Drug Labeling and Warnings

Critic Aid Clear by is a Otc medication manufactured, distributed, or labeled by Coloplast Manufacturing US, LLC, Coloplast Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Minor To Severe
Skin Irritation
Due To Incontinence

• Adheres to denuded skin
• Easy to apply and remove
• Eliminates moisture

SPL UNCLASSIFIED SECTION

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.

DOSAGE & 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.

INACTIVE INGREDIENT

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

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)

INGREDIENTS AND APPEARANCE

CRITIC AID CLEAR 
petrolatum ointment

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	710 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-066-22	4 g in 1 PACKET; Type 0: Not a Combination Product	06/15/2009
2	NDC: 11701-066-33	71 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009
3	NDC: 11701-066-32	170 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE(11701-066)