S-Oint PRODERM: SKIN PROTECTANT OINTMENT

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:45:40

Label at a glance#

ProductS-Oint PRODERM SKIN PROTECTANT
Active ingredientMENTHOL, UNSPECIFIED FORM, ZINC OXIDE
Label structure10 sections

Dosage and administration

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Storage and handling

Store between:15-30°C (59-86°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44% w/w

Zinc Oxide 20.625% w/w

PURPOSE

OTC - PURPOSE SECTION

External Analgesic

Skin Protectant

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Calamine, Glycerine, Phenol, Lanolin, Heavy Liquid Paraffin, Sodium Bicarbonate, Thymol, White Soft Paraffin

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

A moisture barrier that prevents and helps heal skin irritations from;
• Urine • Diarrhea • Perspiration • Fistula drainage • Feeding tube site leakage • Wound drainage (peri-wound skin) • Minor burns • Cuts • Scrapes • Itching

WARNINGS

WARNINGS SECTION

• Not for deep or puncture wounds. • Avoid contact with eyes. • If condition worsens or does not improve within 7 days, consult a doctor

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 skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store between:15-30°C (59-86°F)

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

PROTECTS, SOOTHES AND PROMOTES HEALING

√ Moisture barrier √ Rash relief √ Soothes skin irritation

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

S-Oint19S-Oint19

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-019-302023-02-08C16284748780-1f386c64a-15d5-0266-e053-dadaa90a7c1aS-Oint PRODERM: SKIN PROTECTANT OINTMENT
73921-019-302023-01-30C16284748780-1f386c64a-15d5-0266-e053-dadaa90a7c1aS-Oint PRODERM: SKIN PROTECTANT OINTMENT

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-01973921-019-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
f42b38b2-1d06-bfdd-e053-2a95a90a14772d30cbd3-f940-4a16-b8b0-872c129c6a702023-02-08WarningsExact identifier
spl set id: 2d30cbd3-f940-4a16-b8b0-872c129c6a70

Reported adverse events (FAERS/openFDA)#

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