Label: CRITIC AID SKIN- zinc oxide paste

  • NDC Code(s): 11701-050-32, 11701-050-33
  • Packager: Coloplast Manufacturing US, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Zinc Oxide: 20%

  • Purpose

    Skin Protectant

  • Uses

    • Helps protect minor skin irritation due to diaper rash
    • Protects chafed skin due to diaper rash
    • Helps seal out wetness
  • Warnings

    For external use only.

    When using this product:

    • avoid contact with eyes

    Consult a doctor:

    • if condition worsens or does not improve within 7 days.

    Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean 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.
    • Change wet and soiled absorbent brief/diapers promptly.
  • Inactive ingredients

    Cellulose Gum (CMC), Dimethicone, Petrolatum

  • Questions or comments?

    Call toll free 1-800-533-0464

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Coloplast A/S
    Holtedam 1, DK-3050 Humlebaek, Denmark

    Distributed by: Coloplast Corp
    1601 W River Rd. N, Minneapolis, MN 55411 USA

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Label

    NDC 11701-050-32

    Critic-Aid® Skin Paste

    Skin Protectant

    Thick Moisture
    Barrier Paste

    For Minor to
    Severe Skin Irritation
    Due to Incontinence

    Product #1947

    Coloplast

    NET WT. 6 OZ. (170 g)

    Principal Display Panel - 170 g Tube Label
  • INGREDIENTS AND APPEARANCE
    CRITIC AID SKIN 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-050-3371 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    2NDC:11701-050-32170 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 drugM01506/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-050)
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