FDA.reportPublic FDA data

S-Cream ZINC OXIDE 13%

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:51

Label at a glance#

ProductS-Cream ZINC OXIDE 13%
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

• Helps treat and prevent diaper rash • Protects chafed skin due to diaper rash and helps seal out moisture • Insect bites • Burns minor abrasions • Skin irritation

Dosage and administration

• Change wet and soiled diapers promptly • Cleanse the diaper area • Allow to dry • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may  be prolonged

Storage and handling

store at 20° to 25°C (68°F to 77°F) Protect from freezing May stain clothing

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 13%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Mineral oil, Petrolatum, Beeswax, Dimethicone, Sorbitan sesquioleate, Microcrystalline wax, PEG-30 Dipolyhydroxystearate, Aloe barbadensis leaf extract, Glycerin, Tropolone, Tocopheryl acetate, 1,2-Hexanediol, Caprylyl glycol, Magnesium sulfate, Potassium hydroxide, Phenoxyethanol

USES

INDICATIONS & USAGE SECTION

• Helps treat and prevent diaper rash

• Protects chafed skin due to diaper rash and helps seal out moisture • Insect bites • Burns minor abrasions • Skin irritation

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 the diaper area
• Allow to dry
• Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

OTHER INFORMATION

STORAGE AND HANDLING SECTION

store at 20° to 25°C (68°F to 77°F)
Protect from freezing
May stain clothing

Questions or comments?

OTC - QUESTIONS SECTION

1-800-572-6632 between 9am and 4pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

SKIN PROTECTANT CREAM

Effectively Treats & Prevents:
√ Skin irritation √ Diaper rash
√ Burns √ Cuts / Abrasions

Manufactured by:

Global pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zincoxide13-1Zincoxide13-1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-013-302023-02-08C16284748780-1f386c649-dcc9-0266-e053-dadaa90a7c1aS-Cream ZINC OXIDE 13% SKIN PROTECTANT CREAM
73921-013-302023-01-30C16284748780-1f386c649-dcc9-0266-e053-dadaa90a7c1aS-Cream ZINC OXIDE 13% SKIN PROTECTANT CREAM

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-01373921-013-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
TROPOLONE7L6DL16P1TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f42b2912-248a-7619-e053-2a95a90ae1baf8aa5f9e-c616-4246-924e-15320ece10632023-02-08WarningsExact identifier
spl set id: f8aa5f9e-c616-4246-924e-15320ece1063

Reported adverse events (FAERS/openFDA)#

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