PRIMER- zinc oxide, calamine dressing

Primer by

Drug Labeling and Warnings

Primer by is a Otc medication manufactured, distributed, or labeled by Derma Sciences Canada, 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%

Purpose

Skin Protectant

Uses

• Dries the oozing and weeping of poison ivy, poison oak, or poison sumac.
• Ideal for managing extremities (e.g., varicose ulcers) requiring protection and support.
  

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

• Begin bandaging at base of toes, without pressure, keeping foot and leg at right angle. Continue bandaging beyond ankle, doubling back to ensure molding to contours of leg (STEP 1).
• Continue bandaging to just below the knees (STEP 2).
• Apply an elastic adhesive bandage (STEP 3).
  

Other Ingredients

Acacia, Castor oil, Glycerin, and White Petrolatum.

Principal Display Panel (Front and Back)

(FRONT SIDE NDC: 64772-300-05)

NDC: 64772-300-05

Primer ®

3" Modified Unna Boot with Calamine

3" Venda Bota
Unna Modificada Con Calamina

Stays moist
to Encourage
Healing

Permanece
humeda para
alentar
la curacion

Catalog # R99903C

DERMA SCIENCES

(FRONT SIDE NDC: 64772-300-03)

NDC: 64772-300-03

Primer ®

3" Modified Unna Boot with Calamine

3" Venda Bota
Unna Modificada Con Calamina

Stays moist
to Encourage
Healing

Permanece
humeda para
alentar
la curacion

Catalog # GL300-1C

DERMA SCIENCES

(BACK SIDE NDC: 64772-300-03)

Primer ®

3" Modified Unna Boot with Calamine

• Non - raveling guaze evenly impregnated with a non-hardening zinc oxide paste
  
• Contains no preservatives

3" Venda Unna Modificada Con Calamina

• Venda ge gasa gue no se deshila impregnada uniformemente con pasta de oxido de zinc que no se endurece.
• No contiene conservadores.

Catalog # GL300-1C

DERMA SCIENCES

(FRONT SIDE NDC: 64772-300-06)

NDC: 64772-300-06

Primer ®

4" Modified Unna Boot with Calamine

4" Venda Bota
Unna Modificada Con Calamina

Stays moist
to Encourage
Healing

Permanece
humeda para
alentar
la curacion

Catalog # R99904C

DERMA SCIENCES

(FRONT SIDE NDC: 64772-300-04)

NDC: 64772-300-04

Primer ®

4" Modified Unna Boot with Calamine

4" Venda Bota
Unna Modificada Con Calamina

Stays moist
to Encourage
Healing

Permanece
humeda para
alentar
la curacion

Catalog # GL-400-1C

DERMA SCIENCES

(BACK SIDE NDC: 64772-300-04)

Primer ®

4" Modified Unna Boot with Calamine

• Non - raveling guaze evenly impregnated with a non-hardening zinc oxide paste
• Contains no preservatives

4" Venda Unna Modificada Con Calamina

• Venda ge gasa gue no se deshila impregnada uniformemente con pasta de oxido de zinc que no se endurece.
• No contiene conservadores.

Catalog # GL-400-1C

DERMA SCIENCES

INGREDIENTS AND APPEARANCE

PRIMER 
zinc oxide, calamine dressing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64772-300
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	0.015 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	0.985 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: 64772-300-03	1 in 1 BOX
2	NDC: 64772-300-05	60 in 1 BOX
3	NDC: 64772-300-04	1 in 1 BOX
4	NDC: 64772-300-06	60 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/10/2010

Labeler - Derma Sciences Canada, Inc. (200564891)

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