Dr Smiths Diaper Rash

Manufacturer: Mission Pharmacal Company | FORMULATED SOLUTIONS, LLC
Effective date: 2017-12-06
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 01:09:12

Label at a glance#

ProductDr Smiths Diaper Rash

Active ingredientZINC OXIDE

Label structure9 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

change wet and soiled diapers promptly cleanse diaper area allow to dry shake well before each use spray liberally onto affected area as often as needed or with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

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 diaper rash
protects chafed skin due to diaper rash and helps seal out 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

change wet and soiled diapers promptly
cleanse diaper area
allow to dry
shake well before each use
spray liberally onto affected area as often as needed or with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

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

DRS Diaper Rash Spray

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-0340-03	GM - Gram	0178-0340	49b1b32f-796c-4aae-9024-b0b6caa96911	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
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
MAGNESIUM SULFATE, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0178-0340	0178-0340-03

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
C12-15 ALKYL LACTATE	GC844VRD7E	IACT
OCTYLDODECANOL	461N1O614Y	IACT
PEG-30 DIPOLYHYDROXYSTEARATE	9713Q0S7FO	IACT
PROPYLENE GLYCOL	6DC9Q167V3	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
ZINC OXIDE	SOI2LOH54Z	ACTIB
MAGNESIUM SULFATE, UNSPECIFIED FORM	DE08037SAB	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
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SOLUTION / ORAL		5566 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CREAM / TOPICAL		3300 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / VAGINAL	0.03 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 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	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 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 / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 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	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
MAGNESIUM SULFATE	MAGNESIUM SULFATE	DE08037SAB	TABLET, FILM COATED / ORAL	14 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	SUPPOSITORY / RECTAL		390 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	LOTION / TOPICAL		7 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 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
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, EXTENDED RELEASE / ORAL	0.37 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 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
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 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	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	AEROSOL, FOAM / TOPICAL	10.87 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 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
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	LOTION / TOPICAL	7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, FILM COATED / ORAL		12 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		5 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 78 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	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / TOPICAL		225 mg	Exact identifier — unii candidate 13 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
d3d12399-9d83-1f5a-e053-2995a90adcb3			2e655e6a-3a72-70c4-95f6-8faa8e4d0c8d	2021-12-23	Warnings	Exact identifier spl set id: 2e655e6a-3a72-70c4-95f6-8faa8e4d0c8d

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#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#