Label: REPARA - zinc oxide, ferric oxide red and zinc oxide dressing 

  • Label RSS
  • NDC Code(s): 68345-272-01, 68345-272-02
  • Packager: PSS World Medical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/10

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Zinc Oxide 25%

    Calamine 1.3%

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  • Purpose

    Skin Protectant

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  • Uses


    Dries the oozing and weeping of poison:
    • ivy
    • oak
    • sumac
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  • Warning

    For external use only.

    When using this product

    • do not get into eyes

    Stop and ask a doctor if

    • Condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

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

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  • Directions

    • Apply as needed
    • Cleanse the leg and dry the skin.
    • If a wound is present, apply an appropriate wound dressing for moist wound healing.
    • With a foot positioned at 90o or right angle to the leg (dorsiflexed) begin wrapping the medicated bandage without tension beginning at the base of the toes. Wrap the leg without tension overlapping each layer by 50% or half the width of the dressing. Smooth and mold the bandage while wrapping.
    • Wrap all the way up the leg stopping one finger width below the posterior knee.
    • Apply an elastic adhesive bandage (not included), following the manufacturer's instructions.
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  • Other Ingredients

    Acacia, Castor oil, Glycerin, and White Petrolatum.

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  • Principal Display Panel (Front and Back)


    NDC # 68345-272-01

    REPARA®

    3" Unna Boot w/ Calamine

    • 3" x 10 yds.
    • Non-hardening zinc oxide formulation
    • Conforms easily to foot or leg
    • Provides moist healing environment
    Questions or Comments about Repara
    Products? 800-777-4908

    Manufactured for PSS World Medical Inc.
    4345 Southpoint Blvd., Jacksonville, FL 32216
    Made in Mexico
    www.myselectonline.com

    1 each/box

    Reorder # 2072

    Directions for Use

    1. Cleanse the leg and dry the skin.
    2. If a wound is present, apply an appropriate wound dressing for moist wound healing.
    3. With the foot positioned at a 90 or right angle to the leg (dorsiflexed) begin wrapping the medicated bandage without tension beginning at the base of the toes. Wrap the leg without tension overlapping each layer by 50% or half the width of the dressing. Smooth and mold the bandage while wrapping.
    4. Wrap all the way up the leg stopping one finger width below the posterior knee.
    5. Apply an adhesive bandage (not included), following the manufacturer's instructions
      Repara 3 " Unna Boot with calamine
    NDC # 68345-272-02

    REPARA®

    4" Unna Boot w/ Calamine

    • 4" x 10 yds.
    • Non-hardening zinc oxide formulation
    • Conforms easily to foot or leg
    • Provides moist healing environment
    Questions or Comments about Repara
    Products? 800-777-4908

    Manufactured for PSS World Medical Inc.
    4345 Southpoint Blvd., Jacksonville, FL 32216
    Made in Mexico
    www.myselectonline.com

    1 each/box

    Reorder # 2073

    Directions for Use

    1. Cleanse the leg and dry the skin.
    2. If a wound is present, apply an appropriate wound dressing for moist wound healing.
    3. With the foot positioned at a 90 or right angle to the leg (dorsiflexed) begin wrapping the medicated bandage without tension beginning at the base of the toes. Wrap the leg without tension overlapping each layer by 50% or half the width of the dressing. Smooth and mold the bandage while wrapping.
    4. Wrap all the way up the leg stopping one finger width below the posterior knee.
    5. Apply an adhesive bandage (not included), following the manufacturer's instructions.
      Repara 4" Unna Boot with calamine
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  • INGREDIENTS AND APPEARANCE
    REPARA 
    zinc oxide, calamine dressing
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68345-272
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC CATION) ZINC OXIDE 25 g
    FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED 0.0195 g
    ZINC OXIDE (ZINC CATION) ZINC OXIDE 1.2805 g
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    CASTOR OIL  
    GLYCERIN  
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68345-272-01 1 in 1 BOX
    2 NDC:68345-272-02 1 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 05/17/2010
    Labeler - PSS World Medical, Inc. (101822682)
    Registrant - LABORATORIOS LE ROY, S.A. DE C.V. (588387394)
    Establishment
    Name Address ID/FEI Business Operations
    LABORATORIOS LE ROY, S.A. DE C.V. 588387394 manufacture
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