FDA.reportPublic FDA data

Primer

Manufacturer
Derma Sciences Canada, Inc. | LABORATORIOS LE ROY, S.A. DE C.V.
Effective date
2010-05-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:53:13

Label at a glance#

ProductPrimer
Active ingredientZINC OXIDE, FERRIC OXIDE RED
Label structure7 sections

Indications and 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.

Dosage and administration

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).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Calamine 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of children's reach.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

Acacia, Castor oil, Glycerin, and White Petrolatum.

Principal Display Panel (Front and Back)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

(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
Label 3" Modified Unna boot with Calamine Label
Label 3" Modified Unna boot with Calamine Label


(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
Label 4" Modified Unna boot with Calamine Label
Label 4" Modified Unna boot with Calamine Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64772-300-032025-12-31C16284748780-1956f9ecf-bd8a-621f-e053-dbdaa90a74adDrug Facts
64772-300-042025-12-31C16284748780-1956f9ecf-bd8a-621f-e053-dbdaa90a74adDrug Facts
64772-300-052025-12-31C16284748780-1956f9ecf-bd8a-621f-e053-dbdaa90a74adDrug Facts
64772-300-062025-12-31C16284748780-1956f9ecf-bd8a-621f-e053-dbdaa90a74adDrug Facts
64772-300-032019-10-21C16284748780-1956f9ecf-bd8a-621f-e053-dbdaa90a74adDrug Facts
64772-300-042019-10-21C16284748780-1956f9ecf-bd8a-621f-e053-dbdaa90a74adDrug Facts
64772-300-052019-10-21C16284748780-1956f9ecf-bd8a-621f-e053-dbdaa90a74adDrug Facts
64772-300-062019-10-21C16284748780-1956f9ecf-bd8a-621f-e053-dbdaa90a74adDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64772-300PRIMER (ZINC OXIDE, CALAMINE) DRESSING [DERMA SCIENCES CANADA, INC.]2Legacy NDC20100512_dbc393f1-4a62-4f15-af2d-6f21f4ee6c4a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G6752
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
FERRIC OXIDE REDACTIVE MOIETY1K09F3G6752
ZINC CATIONACTIVE MOIETY13S1S8SF372
ACACIAINACTIVE INGREDIENT5C5403N26O2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64772-30064772-300-03, 64772-300-05, 64772-300-04, 64772-300-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ACACIA5C5403N26OIACT
CASTOR OILD5340Y2I9GIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 128 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ACACIAACACIA5C5403N26OLOZENGE / ORAL108 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, FILM COATED / ORAL15.29 mgExact identifier — unii candidate
16 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, FILM COATED / ORAL0.14 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OCAPSULE / ORAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER, FOR SUSPENSION / ORAL7386 mgExact identifier — unii candidate
19 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER / ORAL800 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OSUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / BUCCAL9.1 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, EXTENDED RELEASE / ORAL34.4 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OGUM, CHEWING / BUCCAL280 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
362067e2-50de-4bc4-a414-b2fcf23b567cdbc393f1-4a62-4f15-af2d-6f21f4ee6c4a2025-12-29WarningsExact identifier
spl set id: dbc393f1-4a62-4f15-af2d-6f21f4ee6c4a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.