Label: CRITIC AID CLEAR- petrolatum ointment

  • NDC Code(s): 11701-066-22, 11701-066-32, 11701-066-33
  • Packager: Coloplast Manufacturing US, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • 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)

    PRINCIPAL DISPLAY PANEL - NET WT. 6 OZ. (170 g)
  • INGREDIENTS AND APPEARANCE
    CRITIC AID CLEAR 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM710 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-066-224 g in 1 PACKET; Type 0: Not a Combination Product06/15/2009
    2NDC:11701-066-3371 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    3NDC:11701-066-32170 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01606/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-066)
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