Label: REPARA- zinc oxide, calamine dressing
-
Contains inactivated NDC Code(s)
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
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 14, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warning
-
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
-
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
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
- Cleanse the leg and dry the skin.
- If a wound is present, apply an appropriate wound dressing for moist wound healing.
- 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.
- Wrap all the way up the leg stopping one finger width below the posterior knee.
- Apply an adhesive bandage (not included), following the manufacturer's instructions
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
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
- Cleanse the leg and dry the skin.
- If a wound is present, apply an appropriate wound dressing for moist wound healing.
- 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.
- Wrap all the way up the leg stopping one finger width below the posterior knee.
- Apply an adhesive bandage (not included), following the manufacturer's instructions.
-
INGREDIENTS AND APPEARANCE
REPARA
zinc oxide, calamine dressingProduct 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