Comfort Shield Barrier Cream Cloths

Manufacturer: Sage Products LLC
Effective date: 2026-06-23
Label type: HUMAN OTC DRUG LABEL
Version: 17
Source: monthly-update
Hydrated at: 2026-07-17 21:35:29

Label at a glance#

ProductComfort Shield Barrier

Active ingredientDIMETHICONE

Label structure8 sections

Indications and uses

helps seal out wetness helps treat and prevent perineal dermatitis protects from minor skin irritation associated with perineal dermatitis

Dosage and administration

remove wet and soiled garment cleanse soiled area using a fresh barrier cream cloth discard cloth after use - DO NOT FLUSH CLOTHS use as often as necessary, especially if prolonged exposure to wetness is anticipated for individual use only reseal label between uses discard package immediately if cloths are dry peel open label without completely removing it heat entire package in microwave no longer than [see packa...

Contacts and useful links#

PhoneLabel contact800-323-2220

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 3%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

helps seal out wetness
helps treat and prevent perineal dermatitis
protects from minor skin irritation associated with perineal dermatitis

Warnings

WARNINGS SECTION

For external perineal use only.
Avoid contact with the eyes.

OTC - STOP USE SECTION

Stop use and consult a doctor if condition worsens or does not improve within 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

remove wet and soiled garment
cleanse soiled area using a fresh barrier cream cloth
discard cloth after use - DO NOT FLUSH CLOTHS
use as often as necessary, especially if prolonged exposure to wetness is anticipated
for individual use only
reseal label between uses
discard package immediately if cloths are dry

If warming is desired:

SPL UNCLASSIFIED SECTION

peel open label without completely removing it
heat entire package in microwave no longer than [see package for time].
since microwave wattage varies, adjust heating time accordingly
Comfort Shield® may also be used at room temperature or warmed in a Comfort Personal Cleansing Warmer.
Caution: If there is any indication barrier cloths are excessively hot, do not use
Remember, gloves diminish your sensitivity to heat
Closely monitor heat level with infants, unresponsive or skin sensitive individuals

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, cetyl alcohol, glycerin, stearyl alcohol, phenoxyethanol, methylpropanediol, chlorhexidine gluconate, hydroxyethyl cellulose, ethylhexylglycerin, polyquaternium-37, propylene glycol dicaprylate/dicaprate, glucono-delta-lactone, PPG-1 trideceth-6

Barrier cloths: cellulose fiber/polyester (PET) fiber

Questions or Comments?

OTC - QUESTIONS SECTION

800-323-2220

Comfort Shield Barrier

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

R5549_7803R4157NR5545R6223BR5548R5567C

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53462-915-50	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-02-22	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-01-28	C162847	48780-1	d6a99b39-4a60-a426-e053-dadaa90af4c2	Comfort Shield Barrier Cream Cloths

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53462-915-50	EA - Each	53462-915	86d72459-ae42-4f14-82c1-9a3562488a17	1	2012-07-24
53462-915-51	EA - Each	53462-915	8f65a50a-b111-45b6-92fc-cb0281b43583	1	2012-07-24
53462-915-60	EA - Each	53462-915	5e281b48-6ba9-471a-a477-dd3fed32e90c	1	2012-07-24
53462-915-80	EA - Each	53462-915	25b8c726-486d-4f6d-bc84-a120976ca2bb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	6
dimethicone	ACTIVE MOIETY	92RU3N3Y1O	6
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	6
chlorhexidine gluconate	INACTIVE INGREDIENT	MOR84MUD8E	6
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	6
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	6
hydroxyethyl cellulose (4000 MPA.S at 1%)	INACTIVE INGREDIENT	ZYD53NBL45	6
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	6
PEG-100 stearate	INACTIVE INGREDIENT	YD01N1999R	6
PPG-15 STEARYL ETHER	INACTIVE INGREDIENT	1II18XLS1L	6
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	6
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	6
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	6
water	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

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

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

Comfort Shield Barrier
dimethicone
WATER
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
ISOPROPYL PALMITATE
CETYL ALCOHOL
GLYCERIN
STEARYL ALCOHOL
PHENOXYETHANOL
METHYLPROPANEDIOL
CHLORHEXIDINE GLUCONATE
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
ETHYLHEXYLGLYCERIN
POLYQUATERNIUM-37 (25000 MPA.S)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE
GLUCONOLACTONE
PPG-1 TRIDECETH-6

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53462-915	53462-915-50, 53462-915-51, 53462-915-62, 53462-915-80, 53462-915-81, 53462-915-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERIN	PDC6A3C0OX	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
METHYLPROPANEDIOL	N8F53B3R4R	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	ZYD53NBL45	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
POLYQUATERNIUM-37 (25000 MPA.S)	31L31U8285	IACT
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE	O4446S9CRA	IACT
GLUCONOLACTONE	WQ29KQ9POT	IACT
PPG-1 TRIDECETH-6	1K7417JX6Q	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
16	2025-10-20	full-release	2026-06-01 01:40:36
15	2024-11-14	full-release	2026-06-01 00:37:52

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 7 · 371 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
stearic acid	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii+route 56 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii+route 56 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route 91 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii+route 91 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route 98 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii+route 56 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii+route 98 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 91 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii+route 35 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii+route 56 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 98 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route 98 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+route 56 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii+route 35 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii+route 56 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+route 56 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii+route 98 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii+route 98 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii+route 91 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii+route 56 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 98 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii+route 91 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 91 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii+route 98 equally ranked IID candidates
stearyl alcohol	STEARYL ALCOHOL	2KR89I4H1Y	OINTMENT / TOPICAL		569 mg	Exact identifier — unii+route 35 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii+route 98 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii+route 91 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii+route 56 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii+route 91 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii+route 35 equally ranked IID candidates
stearyl alcohol	STEARYL ALCOHOL	2KR89I4H1Y	AEROSOL, FOAM / TOPICAL		37 mg	Exact identifier — unii+route 35 equally ranked IID candidates
hydroxyethyl cellulose (4000 MPA.S at 1%)	HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	ZYD53NBL45	GEL / TOPICAL		231 mg	Exact identifier — unii+route 14 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii+route 91 equally ranked IID candidates
PPG-15 STEARYL ETHER	POLYPROPYLENE GLYCOL 15 STEARYL ETHER	1II18XLS1L	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii+route 56 equally ranked IID candidates
stearyl alcohol	STEARYL ALCOHOL	2KR89I4H1Y	AEROSOL, FOAM / TOPICAL		37 mg	Exact identifier — unii+route 35 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii+route 35 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii+route 91 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route 91 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii+route 98 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii+route 56 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route 91 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii+route 98 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii+route 98 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii+route 98 equally ranked IID candidates
stearyl alcohol	STEARYL ALCOHOL	2KR89I4H1Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii+route 35 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii+route 91 equally ranked IID candidates
hydroxyethyl cellulose (4000 MPA.S at 1%)	HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	ZYD53NBL45	SOLUTION / TOPICAL	0.26 %w/v		Exact identifier — unii+route 14 equally ranked IID candidates
hydroxyethyl cellulose (4000 MPA.S at 1%)	HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	ZYD53NBL45	SOLUTION / TOPICAL	0.26 %w/v		Exact identifier — unii+route 14 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii+route 98 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii+route 91 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii+route 98 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route 98 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii+route 91 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii+route 91 equally ranked IID candidates
stearyl alcohol	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route 35 equally ranked IID candidates
stearyl alcohol	STEARYL ALCOHOL	2KR89I4H1Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii+route 35 equally ranked IID candidates
hydroxyethyl cellulose (4000 MPA.S at 1%)	HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	ZYD53NBL45	GEL / TOPICAL		231 mg	Exact identifier — unii+route 14 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+route 35 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
Comfort Shield Barrier	DIMETHICONE	Sage Products LLC	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	2026-06-23	Warnings	Exact identifier ndc (package): 53462-915-51 ndc (package): 53462-915-62 ndc (package): 53462-915-80 ndc (package): 53462-915-81 ndc (package): 53462-915-50 ndc (package): 53462-915-24 ndc (product): 53462-915 ndc11 (package): 53462091550 ndc11 (package): 53462091581 ndc11 (package): 53462091524 ndc11 (package): 53462091551 ndc11 (package): 53462091580 ndc11 (package): 53462091562 spl id: 54ee06dc-1e51-3f8a-e063-6294a90a1fb0 spl set id: cc08f571-84ae-4c2f-b09d-a83a8efc39f5

Reported adverse events (FAERS/openFDA)#

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