FDA.reportPublic FDA data

Baza Protect - Coloplast Corp | Coloplast Corp. | Medline Industries, LP

Manufacturer
Coloplast Corp | Coloplast Corp. | Medline Industries, LP
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:52:25

Label at a glance#

ProductBaza Protect
Active ingredientZINC OXIDE, DIMETHICONE, UNSPECIFIED
Label structure3 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For Skin Irritation Due to Incontinence

  • Protects
  • Easy to apply and remove
  • Seals out wetness

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Zinc Oxide, 12%

Dimethicone, 1 %

OTC - PURPOSE SECTION

Purpose

Diaper Rash

Skin Protectant

INDICATIONS & USAGE SECTION

Uses Helps treat and prevent minor skin irritation due to

diaper rash. Helps seal out wetness.

WARNINGS SECTION

Warnings

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes
  • not to be applied over deep or puncture wounds or lacerations.

OTC - ASK DOCTOR SECTION

Consult a doctor

  • if condition worsens or does not improve within 7 days.

SPL UNCLASSIFIED SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control

Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • change wet and soiled diapers promptly
  • apply to affected area and gently wipe with clean, soft cloth
  • apply as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

INACTIVE INGREDIENT SECTION

Inactive ingredients

BHT, cetyl alcohol, cod liver oil, EDTA, fragrance, glyceryl stearate, lanolin oil, PEG-8 stearate, PEG-40 stearate, petrolatum, propylene glycol, quaternium-15, tocopheryl acetate, tricontanyl PVP, water

See crimp for lot no. and expiration date

Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.cobplast.com
Product #1880 ©2008-7, Coloplast Corp.
Made in the U.S.A.

G8-773

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)

NDC 11701-046-14

Baza®Protect

Skin Protectant

Moisture Barrier Cream

For Skin Irritation Due to Incontinence

Coloplast

NET WT. 5 OZ. (142 g)

PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)
PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053158Baza Protect 1 % / 12 % Topical CreamPSN10
637565dimethicone 1 % / zinc oxide 12 % Topical CreamPSN10
1053158dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical Cream [Baza-Protect]SBD10
637565dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical CreamSCD10
1053158Baza Protect (dimethicone 1 % / zinc oxide 12 % ) Topical CreamSY10
637565dimethicone 1 % / zinc oxide 12 % Topical CreamSY10
637565dimethicone 10 MG/ML / ZNO 120 MG/ML Topical CreamSY10
1053158dimethicone 10 MG/ML / ZNO 120 MG/ML Topical Cream [Baza-Protect]SY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11701-046-142024-12-26C16284748780-1f386c649-e202-0266-e053-dadaa90a7c1aBaza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-222024-12-26C16284748780-1f386c649-e202-0266-e053-dadaa90a7c1aBaza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-232024-12-26C16284748780-1f386c649-e202-0266-e053-dadaa90a7c1aBaza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-142023-01-30C16284748780-1f386c649-e202-0266-e053-dadaa90a7c1aBaza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-222023-01-30C16284748780-1f386c649-e202-0266-e053-dadaa90a7c1aBaza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-232023-01-30C16284748780-1f386c649-e202-0266-e053-dadaa90a7c1aBaza ® Protect Skin Protectant Moisture Barrier Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-046-14Baza Protect142 g in 1 TUBECREAM14210
11701-046-22Baza Protect4 g in 1 PACKETCREAM410
11701-046-23Baza Protect57 g in 1 TUBECREAM5710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-046-14GM - Gram11701-046847abd0e-98eb-494d-b496-6c0e33fd2d2b12012-07-24
11701-046-22GM - Gram11701-04611036513-eb3d-484e-a6da-cb427d921f0512012-07-24
11701-046-23GM - Gram11701-04692ec4e91-3758-476b-bf89-eda39619d72412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O4
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z4
DIMETHICONEACTIVE MOIETY92RU3N3Y1O4
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z4
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN4
COD LIVER OILINACTIVE INGREDIENTBBL281NWFG4
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV04
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE44
LANOLININACTIVE INGREDIENT7EV65EAW6H4
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q74
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5E4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
QUATERNIUM-15INACTIVE INGREDIENTE40U03LEM04
TRIACONTANYL PVP (WP-660)INACTIVE INGREDIENTN0SS3Q238D4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11701-04611701-046-22, 11701-046-23, 11701-046-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
PEG-8 MONOSTEARATE2P9L47VI5EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-40 MONOSTEARATEECU18C66Q7IACT
EDETIC ACID9G34HU7RV0IACT
COD LIVER OILBBL281NWFGIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
QUATERNIUM-15E40U03LEM0IACT
WATER059QF0KO0RIACT

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 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEG-8 STEARATEPEG-8 MONOSTEARATE2P9L47VI5ECREAM / TOPICAL229 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0CREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0CREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0CREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0CREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEG-8 STEARATEPEG-8 MONOSTEARATE2P9L47VI5ECREAM / TOPICAL229 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEG-8 STEARATEPEG-8 MONOSTEARATE2P9L47VI5ECREAM / TOPICAL229 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEG-8 STEARATEPEG-8 MONOSTEARATE2P9L47VI5ECREAM / TOPICAL229 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
4 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
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corped63df26-3879-46df-8e09-10be569b25be2026-03-31WarningsExact identifier
ndc (package): 11701-046-23
ndc (package): 11701-046-22
ndc (package): 11701-046-14
ndc (product): 11701-046
ndc11 (package): 11701004614
ndc11 (package): 11701004622
ndc11 (package): 11701004623
spl id: a888e9dc-9ced-4e46-9aba-6570c65ad11f
spl set id: ed63df26-3879-46df-8e09-10be569b25be

Reported adverse events (FAERS/openFDA)#

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