PRIMER - zinc oxide dressing 
Derma Sciences Canada, Inc.

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.

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Drug Facts

Active Ingredients

Zinc Oxide 25%

Purpose

Skin Protectant

Uses

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

Other Ingredients

Acacia, Castor oil, Glycerin, and White Petrolatum.

Principal Display Panel (Front and Back)

(FRONT SIDE NDC 64772-302-05)

NDC 64772-302-05

Primer ®

3" Modified Unna Boot

3" Venda Bota
Unna Modificada

3" x 10 yds.

(7.6 cm x 9.1 m)

Stays moist
to Encourage
Healing

Permanece
humeda para
alentar
la curacion

Catalog # R99903

DERMA SCIENCES


(FRONT SIDE NDC 64772-302-03)

NDC 64772-302-03

Primer ®

3" Modified Unna Boot

3" Venda Bota
Unna Modificada

3" x 10 yds.

(7.6 cm x 9.1 m)

Stays moist
to Encourage
Healing

Permanece
humeda para
alentar
la curacion

Catalog # GL300-1

DERMA SCIENCES

(BACK SIDE OF NDC 64772-302-03)

Primer ®

3" Modified Unna Boot

3" Venda Unna Modificada

Catalog # GL300-1

DERMA SCIENCES
Label 3" Modified Unna boot Label


(FRONT SIDE NDC 64772-302-06)

NDC 64772-302-06

Primer ®

4" Modified Unna Boot

4" Venda Bota
Unna Modificada

4" x 10 yds.

(10.2 cm x 9.1 m)

Stays moist
to Encourage
Healing

Permanece
humeda para
alentar
la curacion

Catalog # R99904

DERMA SCIENCES

(FRONT SIDE NDC 64772-302-04)

NDC 64772-302-04

Primer ®

4" Modified Unna Boot

4" Venda Bota
Unna Modificada

4" x 10 yds.

(10.2 cm x 9.1 m)

Stays moist
to Encourage
Healing

Permanece
humeda para
alentar
la curacion

Catalog # GL-400-1

DERMA SCIENCES

(BACK SIDE NDC 64772-302-04)

Primer ®

4" Modified Unna Boot

4" Venda Unna Modificada

Catalog # GL-400-1

DERMA SCIENCES
Label 4" Modified Unna boot Label
PRIMER 
zinc oxide dressing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64772-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE25 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:64772-302-031 in 1 BOX
2NDC:64772-302-0560 in 1 BOX
3NDC:64772-302-041 in 1 BOX
4NDC:64772-302-0660 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

Revised: 5/2010
Document Id: 3782c8e9-49e7-4f8a-af24-93c2201133e0
Set id: cf17fff3-f70d-4456-a5a7-c5b15b817d1a
Version: 2
Effective Time: 20100510
 
Derma Sciences Canada, Inc.