Dr Smiths Diaper Rash

Manufacturer: Mission Pharmacal Company | FORMULATED SOLUTIONS, LLC
Effective date: 2014-08-14
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:35:25

Label at a glance#

ProductDr Smiths Diaper Rash

Active ingredientZINC OXIDE

Label structure9 sections

Indications and uses

helps treat and prevent rash caused by adult incontinence protects chafed skin from wetness

Dosage and administration

cleanse the affected area allow to dry shake well before each use spray liberally onto affected area as often as needed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient	Purpose
Zinc Oxide 10%	Skin Protectant

USES

OTC - PURPOSE SECTION

helps treat and prevent rash caused by adult incontinence
protects chafed skin from wetness

WARNINGS

WARNINGS SECTION

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few 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

cleanse the affected area
allow to dry
shake well before each use
spray liberally onto affected area as often as needed

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

do not puncture or incinerate, contents under pressure.
do not store at temperatures above 120°F
store between 15°–30°C (59°–86°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aluminum starch octenylsuccinate, C12-15 alkyl lactate, caprylic/capric triglyceride, cetyl PEG/PPG-10/1 dimethicone, disiloxane, fragrance, hexyl laurate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, magnesium sulfate, methylparaben, octyldodecanol, octyldodecyl xyloside, peg-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, polysorbate 60, polysorbate 80, propylene glycol, propylparaben, sorbitan oleate, squalane, thymol iodide, trans-1,3,3,3-tetrafluorprop-1-ene, triethoxycaprylylsilane, water

To report a serious adverse event or obtain product information, call (210) 696–8400.

SPL UNCLASSIFIED SECTION

Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX 78230 1355

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Smith’s Rash and Skin Spray
NDC 0178–0345–03

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1494203	DR. SMITH'S DIAPER RASH (Topical)	zinc oxide 100 MG/ML Topical Spray [Dr. Smith's Diaper Rash]	SBD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0178-0345-03	2021-12-23	C162847	48780-1	9d75b9d0-73ea-f424-e053-dadaa90a57ce	Drug Facts
0178-0345-03	2020-01-31	C162847	48780-1	9d75b9d0-73ea-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-0345-03	GM - Gram	0178-0345	d78c8703-97cd-4ace-990d-625be3698552	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	2
1,3,3,3-TETRAFLUOROPROPENE, (1E)-	INACTIVE INGREDIENT	5I2481UOO8	2
C12-15 ALKYL LACTATE	INACTIVE INGREDIENT	GC844VRD7E	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	2
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	2
PEG-30 DIPOLYHYDROXYSTEARATE	INACTIVE INGREDIENT	9713Q0S7FO	2
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM ACRYLOYLDIMETHYLTAURATE	INACTIVE INGREDIENT	2T9Q6EKI0G	2
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	2
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	2
THYMOL IODIDE	INACTIVE INGREDIENT	A51HJM3XSU	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

Dr Smiths Diaper Rash
Zinc Oxide
C12-15 ALKYL LACTATE
OCTYLDODECANOL
PEG-30 DIPOLYHYDROXYSTEARATE
PROPYLENE GLYCOL
MAGNESIUM SULFATE
DIMETHICONE
WATER
POLYGLYCERYL-4 ISOSTEARATE
HEXYL LAURATE
THYMOL IODIDE
SODIUM ACRYLOYLDIMETHYLTAURATE
SQUALANE
POLYSORBATE 60
POLYSORBATE 80
SORBITAN MONOOLEATE
METHYLPARABEN
PROPYLPARABEN
1,3,3,3-TETRAFLUOROPROPENE, (1E)-
MEDIUM-CHAIN TRIGLYCERIDES

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0178-0345	0178-0345-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
C12-15 ALKYL LACTATE	GC844VRD7E	IACT
OCTYLDODECANOL	461N1O614Y	IACT
PEG-30 DIPOLYHYDROXYSTEARATE	9713Q0S7FO	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
MAGNESIUM SULFATE	DE08037SAB	IACT
DIMETHICONE	92RU3N3Y1O	IACT
WATER	059QF0KO0R	IACT
POLYGLYCERYL-4 ISOSTEARATE	820DPX33S7	IACT
HEXYL LAURATE	4CG9F9W01Q	IACT
THYMOL IODIDE	A51HJM3XSU	IACT
SODIUM ACRYLOYLDIMETHYLTAURATE	2T9Q6EKI0G	IACT
SQUALANE	GW89575KF9	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
1,3,3,3-TETRAFLUOROPROPENE, (1E)-	5I2481UOO8	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	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 7 · 374 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CREAM / TOPICAL		3300 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAVENOUS		1170 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	SOLUTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SPRAY, METERED / SUBLINGUAL		110 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	GEL / TOPICAL		20 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / TOPICAL	2.85 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	OINTMENT / TOPICAL	2 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	FILM / TRANSDERMAL	32.44 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	LOTION / TOPICAL		7 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	INJECTION, EMULSION / INTRAVENOUS	1.1 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 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
d3d14235-4063-6089-e053-2a95a90ac3c7			04fb7e63-9d49-8dca-91d3-c6d43e0bfd1c	2021-12-23	Warnings	Exact identifier spl set id: 04fb7e63-9d49-8dca-91d3-c6d43e0bfd1c

Reported adverse events (FAERS/openFDA)#

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

Dr Smiths Diaper Rash

Label at a glance#

Indications and uses

Dosage and administration

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

USES

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#