Your browser does not support JavaScript! REPARA (ZINC OXIDE, CALAMINE) DRESSING [PSS WORLD MEDICAL, INC.]
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REPARA (zinc oxide, calamine) dressing
[PSS World Medical, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active Ingredients

Zinc Oxide 25%

Calamine 1.3%

Purpose

Skin Protectant

Uses


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

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.

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.

Other Ingredients

Acacia, Castor oil, Glycerin, and White Petrolatum.

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
REPARA 
zinc oxide, calamine dressing
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68345-272
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC OXIDE25 g
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED0.0195 g
ZINC OXIDE (ZINC CATION) ZINC OXIDE1.2805 g
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CASTOR OIL 
GLYCERIN 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68345-272-011 in 1 BOX
2NDC:68345-272-021 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/17/2010
Labeler - PSS World Medical, Inc. (101822682)
Registrant - LABORATORIOS LE ROY, S.A. DE C.V. (588387394)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS LE ROY, S.A. DE C.V.588387394manufacture

Revised: 5/2010
 
PSS World Medical, Inc.

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