SKIN SAKE Surface Protectant

Manufacturer: Skin Sake, LLC | Memphis Contract Packaging, Inc.
Effective date: 2013-04-24
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:25

Label at a glance#

ProductSKIN SAKE Surface Protectant

Active ingredientDIMETHICONE

Label structure8 sections

Indications and uses

Helps soothe, treat, and prevent ulcer-prone areas, cracked skin, rashes Repels wetness Protects delicate skin Relieves chapped, moist areas Prevents friction

Dosage and administration

Cleanse and dry area. Apply liberally as often as necessary, at least 4 or 5 times per day. Re-apply as needed. Store between 15° -30° C, (59° -86° F)

Contacts and useful links#

PhoneLabel contact1-888-853-5544

Websitewww.skinsake.com

www.skinsake.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredient

Dimethicone 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

Helps soothe, treat, and prevent ulcer-prone areas, cracked skin, rashes
Repels wetness
Protects delicate skin
Relieves chapped, moist areas
Prevents friction

Warnings

WARNINGS SECTION

For external use only.

When using this product, do not get into eyes.

Stop and ask a doctor if condition worsens, symptoms last more than 7 days, or clear up and occur again within a few days.

Do not use on deep or punctured wounds, animal bites, serious burns.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse and dry area. Apply liberally as often as necessary, at least 4 or 5 times per day. Re-apply as needed.

Store between 15° -30° C, (59° -86° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Extract, Acidium Boricum, Castor Oil, Cholecalciferol (Vitamin D), Cod Liver Oil, Green 6, Microcrystalline Wax, Mineral Oil, Myroxylon pereirae (Balsam Peru) Resin, Red 17, Vitamin A, Vitamin E, White Petrolatum, White Wax, Yellow 11

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

www.skinsake.com

SKIN SAKE

Surface Protectant

PHARMACIST FORMULATED

Soothes and Prevents:

Ulcer-Prone Areas
Reddened/Cracked Skin
Incontinent Rashes
Chafed Areas

Repels Wetness
Vitamin A, D, E, and Aloe

NET WT 4OZ SP02

Manufactured for:

Skin Sake

P.O. Box 390

Hamburg, AR 71646

1-888-853-5544

681441-00

SS Surface-Protectant Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
283411	dimethicone 2 % Topical Ointment	PSN	1
283411	dimethicone 0.02 MG/MG Topical Ointment	SCD	1
283411	dimethicone 2 % Topical Ointment	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43447-4410-0	2020-01-31	C162847	48780-1	9d75b9d0-dff9-f424-e053-dadaa90a57ce	c10a5b1c-685c-4219-a20c-8db0b4e00fe7
43447-4410-2	2020-01-31	C162847	48780-1	9d75b9d0-dff9-f424-e053-dadaa90a57ce	c10a5b1c-685c-4219-a20c-8db0b4e00fe7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43447-4410-0	SKIN SAKE Surface Protectant	113.6 g in 1 TUBE	OINTMENT	113.6	1
43447-4410-1	SKIN SAKE Surface Protectant	8 g in 1 PACKET	OINTMENT	8	1
43447-4410-2	SKIN SAKE Surface Protectant	100 in 1 BOX	OINTMENT	100	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43447-4410	SKIN SAKE SURFACE PROTECTANT (DIMETHICONE) OINTMENT [SKIN SAKE, LLC]	1	Legacy NDC, 3 package rows	20130514_c10a5b1c-685c-4219-a20c-8db0b4e00fe7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
BALSAM PERU	INACTIVE INGREDIENT	8P5F881OCY	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	1
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	1
COD LIVER OIL	INACTIVE INGREDIENT	BBL281NWFG	1
D&C GREEN NO. 6	INACTIVE INGREDIENT	4QP5U84YF7	1
D&C RED NO. 17	INACTIVE INGREDIENT	ND733RX3JN	1
D&C YELLOW NO. 11	INACTIVE INGREDIENT	44F3HYL954	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
VITAMIN A	INACTIVE INGREDIENT	81G40H8B0T	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

SKIN SAKE Surface Protectant
DIMETHICONE
ALOE VERA LEAF
BORIC ACID
CASTOR OIL
CHOLECALCIFEROL
COD LIVER OIL
D&C GREEN NO. 6
MICROCRYSTALLINE WAX
MINERAL OIL
BALSAM PERU
D&C RED NO. 17
VITAMIN A
.ALPHA.-TOCOPHEROL
PETROLATUM
WHITE WAX
D&C YELLOW NO. 11

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43447-4410	43447-4410-0, 43447-4410-1, 43447-4410-2

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
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
BORIC ACID	R57ZHV85D4	IACT
CASTOR OIL	D5340Y2I9G	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
COD LIVER OIL	BBL281NWFG	IACT
D&C GREEN NO. 6	4QP5U84YF7	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
MINERAL OIL	T5L8T28FGP	IACT
BALSAM PERU	8P5F881OCY	IACT
D&C RED NO. 17	ND733RX3JN	IACT
VITAMIN A	81G40H8B0T	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
PETROLATUM	4T6H12BN9U	IACT
WHITE WAX	7G1J5DA97F	IACT
D&C YELLOW NO. 11	44F3HYL954	IACT

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 2 · 110 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM, AUGMENTED / TOPICAL	10 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	SOLUTION / ORAL	1.05 mg/1ml		Exact identifier — unii candidate 10 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	OINTMENT / TOPICAL		3575 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.53 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	DROPS / OPHTHALMIC	1 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION / OPHTHALMIC		60 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION, SOLUTION / INTRAMUSCULAR		525 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	GEL / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	CAPSULE / ORAL	1.04 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION / INTRAMUSCULAR		885 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.64 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SPRAY / NASAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, FILM COATED / ORAL	15.29 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / TOPICAL		500 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, FILM COATED / ORAL		246 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION / AURICULAR (OTIC)	0.6 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	EMULSION / OPHTHALMIC		32 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	AEROSOL, FOAM / TOPICAL	2 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET / ORAL		2 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / VAGINAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, CHEWABLE / ORAL	0.1 mg		Exact identifier — unii candidate 10 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
873bd880-3d3e-4e85-a9d6-9fd0c6a9dcbf			c10a5b1c-685c-4219-a20c-8db0b4e00fe7	2013-04-24	Warnings	Exact identifier spl id: 873bd880-3d3e-4e85-a9d6-9fd0c6a9dcbf spl set id: c10a5b1c-685c-4219-a20c-8db0b4e00fe7

Reported adverse events (FAERS/openFDA)#

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