Label: PRIMER- zinc oxide, calamine dressing

  • 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 May 10, 2010

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  • Active Ingredients

    Zinc Oxide 25%

    Calamine 1%

  • Purpose

    Skin Protectant

  • Uses

    • Dries the oozing and weeping of poison ivy, poison oak, or poison sumac.
    • Ideal for managing extremities (e.g., varicose ulcers) requiring protection and support.
  • Warning

    For external use only.

    If condition worsens or does not improve within 7 days, consult a doctor.

    Avoid contact with eyes.

    Keep Out of Reach of Children Section

    Keep this and all medicines out of children's reach.

  • Directions

    • Begin bandaging at base of toes, without pressure, keeping foot and leg at right angle. Continue bandaging beyond ankle, doubling back to ensure molding to contours of leg (STEP 1).
    • Continue bandaging to just below the knees (STEP 2).
    • Apply an elastic adhesive bandage (STEP 3).
  • Other Ingredients

    Acacia, Castor oil, Glycerin, and White Petrolatum.

  • Principal Display Panel (Front and Back)

    (FRONT SIDE NDC 64772-300-05)

    NDC 64772-300-05

    Primer ®

    3" Modified Unna Boot with Calamine

    3" Venda Bota
    Unna Modificada Con Calamina

    Stays moist
    to Encourage
    Healing

    Permanece
    humeda para
    alentar
    la curacion

    Catalog # R99903C

    DERMA SCIENCES


    (FRONT SIDE NDC 64772-300-03)

    NDC 64772-300-03

    Primer ®

    3" Modified Unna Boot with Calamine

    3" Venda Bota
    Unna Modificada Con Calamina

    Stays moist
    to Encourage
    Healing

    Permanece
    humeda para
    alentar
    la curacion

    Catalog # GL300-1C

    DERMA SCIENCES

    (BACK SIDE NDC 64772-300-03)

    Primer ®

    3" Modified Unna Boot with Calamine

    • Non - raveling guaze evenly impregnated with a non-hardening zinc oxide paste
    • Contains no preservatives
    3" Venda Unna Modificada Con Calamina

    • Venda ge gasa gue no se deshila impregnada uniformemente con pasta de oxido de zinc que no se endurece.
    • No contiene conservadores.
    Catalog # GL300-1C

    DERMA SCIENCES
    Label 3" Modified Unna boot with Calamine Label


    (FRONT SIDE NDC 64772-300-06)

    NDC 64772-300-06

    Primer ®

    4" Modified Unna Boot with Calamine

    4" Venda Bota
    Unna Modificada Con Calamina

    Stays moist
    to Encourage
    Healing

    Permanece
    humeda para
    alentar
    la curacion

    Catalog # R99904C

    DERMA SCIENCES

    (FRONT SIDE NDC 64772-300-04)

    NDC 64772-300-04

    Primer ®

    4" Modified Unna Boot with Calamine

    4" Venda Bota
    Unna Modificada Con Calamina

    Stays moist
    to Encourage
    Healing

    Permanece
    humeda para
    alentar
    la curacion

    Catalog # GL-400-1C

    DERMA SCIENCES

    (BACK SIDE NDC 64772-300-04)

    Primer ®

    4" Modified Unna Boot with Calamine
    • Non - raveling guaze evenly impregnated with a non-hardening zinc oxide paste
    • Contains no preservatives
    4" Venda Unna Modificada Con Calamina
    • Venda ge gasa gue no se deshila impregnada uniformemente con pasta de oxido de zinc que no se endurece.
    • No contiene conservadores.
    Catalog # GL-400-1C

    DERMA SCIENCES
    Label 4" Modified Unna boot with Calamine Label
  • INGREDIENTS AND APPEARANCE
    PRIMER 
    zinc oxide, calamine dressing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64772-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE25 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.015 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE0.985 g
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64772-300-031 in 1 BOX
    2NDC:64772-300-0560 in 1 BOX
    3NDC:64772-300-041 in 1 BOX
    4NDC:64772-300-0660 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/10/2010
    Labeler - Derma Sciences Canada, Inc. (200564891)
    Registrant - LABORATORIOS LE ROY, S.A. DE C.V. (588387394)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS LE ROY, S.A. DE C.V.588387394manufacture
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