Baza Cleanse and Protect

Product NDC: 11701-047
11-digit product format: 117010047
Labeler code: 11701
Product ID: 11701-047_da60cbba-9a51-4f0d-a6b4-f677f10406b4
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: LOTION
Route: TOPICAL
Labeler: Coloplast Corp
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-06-15
Substance: DIMETHICONE, UNSPECIFIED
Active strength: 20 mg/g
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Baza Cleanse and Protect
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE, UNSPECIFIED	20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198605	Internal RxNorm lookup
1053200	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82eff041-0c9d-4261-a6b6-5a041a660074	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
11701-047-05	2023-12-21	Baza Cleanse & Protect ® Skin Protectant All-In-One Perineal Lotion
11701-047-22	2023-12-21	Baza Cleanse & Protect ® Skin Protectant All-In-One Perineal Lotion
11701-047-05	2023-01-30	Baza Cleanse & Protect ® Skin Protectant All-In-One Perineal Lotion
11701-047-22	2023-01-30	Baza Cleanse & Protect ® Skin Protectant All-In-One Perineal Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11701-047-05	Baza Cleanse and Protect	227 g in 1 BOTTLE	LOTION	227		7
11701-047-22	Baza Cleanse and Protect	4 g in 1 PACKET	LOTION	4		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11701-047-05	ML - Milliliter	11701-047	9ab1dbf5-8ea4-4b97-96c9-e336d0e5f8e9	1	2012-07-24
11701-047-22	GM - Gram	11701-047	a4f0c42d-5a68-45ac-a118-6b8c8a44189b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
SODIUM LAUROYL LACTYLATE	INACTIVE INGREDIENT	7243K85WFO	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11701-047	BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20231222_82eff041-0c9d-4261-a6b6-5a041a660074.zip

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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERA Calazinc Body Shield	ZINC OXIDE	McKesson Medical-Surgical Inc.	974b1046-83ee-4207-91d3-40982beb9c63	2024-06-17	Warnings	Exact identifier application number: M016
Dimethicone	BODY CLEANSER	McKesson	8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8	2024-06-14	Warnings	Exact identifier application number: M016
Dr. Mom Butt Balm	DIMETHICONE PETROLATUM	Ferndale Laboratories, Inc.	ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd	2024-06-13	Warnings	Exact identifier application number: M016
Secura Protective	PETROLATUM	Smith & Nephew Medical Ltd	20906566-fbf2-46d9-a5d8-c7f7356d1080	2024-06-12	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	NuCare Pharmaceuticals,Inc.	66e98554-e158-a519-e053-2a91aa0a6783	2024-06-06	Warnings, Adverse reactions	Exact identifier application number: M016
CVS Health Vitamin A and D Skin Protectant	LANOLIN AND PETROLATUM	CVS Health	fe3ccabb-9644-4091-9dca-ffd96a43ecaf	2024-05-28	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	186a9642-cd73-adfb-e063-6394a90a75c7	2024-05-14	Warnings	Exact identifier application number: M016
Honest Eczema Balm	COLLOIDAL OATMEAL	The Honest Company, Inc.	35b8bc5c-420e-4d31-9659-f36cabbd897a	2024-05-14	Warnings	Exact identifier application number: M016
Extra Strength Itch Stopping	ITCH STOPPING CREAM	Universal Distribution Centre LLC	b9a42aa3-1903-76f0-e053-2a95a90a51d1	2024-05-13	Warnings	Exact identifier application number: M016
Calamine Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Cardinal Health, 110 dba Leader	7f733c0a-82b2-d3b0-e053-2991aa0a6b0f	2024-05-13	Warnings	Exact identifier application number: M016
Walgreens Maximum Diaper Rash	ZINC OXIDE	Walgreens Company	5eb2152f-6fa2-4191-878a-207416e69818	2024-05-07	Warnings	Exact identifier application number: M016
Cetaphil Eczema Rapid Relief Cream	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	02a405fa-8ae9-41e9-b86f-ef5fb6e3844a	2024-05-02	Warnings	Exact identifier application number: M016
Chapstick	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	0e34fc74-772e-48fd-a353-58807ef412c1	2024-05-01	Warnings	Exact identifier application number: M016
Diaper Rash Cream 40% ZINC	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	16da985a-6210-ec82-e063-6294a90a132d	2024-04-24	Warnings	Exact identifier application number: M016
Petrolatum Jelly	PETROLATUM	ASTONEA LABS PRIVATE LIMITED	16dac8e5-aeb8-592d-e063-6394a90ae2b6	2024-04-24	Warnings	Exact identifier application number: M016
Monistat Complete Care Chafing Relief	DIMETHICONE	Insight Pharmaceuticals LLC	07d7c883-1fa3-4786-905c-a1fab649765e	2024-04-19	Warnings	Exact identifier application number: M016
zinc oxide 20%	ZINC OXIDE 20%	Bionpharma Inc	1549500a-0941-0fba-e063-6394a90a564e	2024-04-18	Warnings	Exact identifier application number: M016
ARC Skin Protectant	ALLANTOIN	Anjon Biologics, Inc	f4ff79dd-cb38-4cca-9631-a2758a171873	2024-04-18	Warnings	Exact identifier application number: M016
Zinctral	ZINC OXIDE	PureTek Corporation	de990834-00da-0c7a-e053-2995a90a7c37	2024-04-15	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Variety Pack	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	bfb9a2d5-1ad2-45b8-a215-9d1370af5337	2024-04-12	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	Dimethicone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1053200	Baza Cleanse and Protect 2 % Topical Lotion	PSN	82eff041-0c9d-4261-a6b6-5a041a660074	7
198605	dimethicone 2 % Topical Lotion	PSN	82eff041-0c9d-4261-a6b6-5a041a660074	7
1053200	dimethicone 20 MG/ML Topical Lotion [Baza Cleanse and Protect]	SBD	82eff041-0c9d-4261-a6b6-5a041a660074	7
198605	dimethicone 20 MG/ML Topical Lotion	SCD	82eff041-0c9d-4261-a6b6-5a041a660074	7
1053200	Baza Cleanse and Protect 2 % Topical Lotion	SY	82eff041-0c9d-4261-a6b6-5a041a660074	7
1053200	Baza Cleanse and Protect 2 % Topical Spray	SY	82eff041-0c9d-4261-a6b6-5a041a660074	7
1053200	Baza Cleanse and Protect 20 MG/ML Topical Lotion	SY	82eff041-0c9d-4261-a6b6-5a041a660074	7
198605	dimethicone 2 % Topical Lotion	SY	82eff041-0c9d-4261-a6b6-5a041a660074	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11701-047-05	11701004705	227 g in 1 BOTTLE (11701-047-05)	227 g	2009-06-15	0000-00-00	No	No	Current
11701-047-22	11701004722	4 g in 1 PACKET (11701-047-22)	4 g	2009-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baza Cleanse & Protect ® Skin Protectant All-In-One Perineal Lotion	Coloplast Corp \| Medline Industries, LP	2026-03-27	HUMAN OTC DRUG LABEL	7