Label: CRITIC AID SKIN- zinc oxide paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated February 21, 2018

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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 finalpart34606/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-050)
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