REPARA- zinc oxide, calamine dressing

REPARA by

Drug Labeling and Warnings

REPARA by is a Otc medication manufactured, distributed, or labeled by PSS World Medical, Inc., LABORATORIOS LE ROY, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
   

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.
   

INGREDIENTS AND APPEARANCE

REPARA 
zinc oxide, calamine dressing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68345-272
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	25 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.0195 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	1.2805 g

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)

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