FDA.reportPublic FDA data

Skin Protectant for Babies and kids

Manufacturer
Neilmed Pharmaceuticals Inc.
Effective date
2026-01-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:31:14

Label at a glance#

ProductSkin Protectant for Babies and kids
Active ingredientLANOLIN, PETROLATUM
Label structure13 sections

Indications and uses

Helps treat and prevent diaper rash Temporarily protects minor cuts, scrapes, and burns Relieves chapped, chafed, or cracked skin and lips Protects from drying effects of wind and cold weather

Dosage and administration

Skin protectant use: apply as needed Diaper rash use: Change wet and soiled diapers promptly Cleanse the diaper area, and allow to dry Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Storage and handling

Do not exceed 30°C (86°F)

Label contents#

Full prescribing information#

Drug Facts: Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lanolin 15.5%

Petrolatum 53.4%

Purpose

OTC - PURPOSE SECTION

Lanolin - Skin protectant

Petrolatum - Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Temporarily protects minor cuts, scrapes, and burns
  • Relieves chapped, chafed, or cracked skin and lips
  • Protects from drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Skin protectant use: apply as needed
  • Diaper rash use:
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area, and allow to dry
  • Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Storage

STORAGE AND HANDLING SECTION

  • Do not exceed 30°C (86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carrot seed oil

Cod liver oil(contains vitamin A & D)

Light mineral oil

Microcrystalline wax

Paraffin wax

Tamper Evident

OTHER SAFETY INFORMATION

  • Do not use if seal on tube is punctured or missing.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton LabelCarton LabelTubeTube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN1
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD1
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY1
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130705928170025GTIN-13: 0705928170025
EAN-13: 0705928170025
GTIN-12: 705928170025
UPC-A: 705928170025
GTIN storage (14 digits): 00705928170025		SPO4-ENU-USL-PK-TU079-DiaperRashOintment-4oz-Rev1-TUBE-V4_page-0001.jpg
QR code linkQR Codeshop.neilmed.com/products/neilmed-skin-protectant-ointmentSPO4-ENU-USL-PK-IC110-DiaperRashOintment-4oz-Rev1-BOX-V9_page-0001.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-352-01Skin Protectant for Babies and kids1 in 1 CARTONOINTMENT11
13709-352-01Skin Protectant for Babies and kids113 g in 1 TUBEOINTMENT1131

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-35213709-352-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE WAXXOF597Q3KYIACT
LANOLIN7EV65EAW6HACTIB
PARAFFINI9O0E3H2ZEIACT
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UACTIB
CARROT SEED OIL595AO13F11IACT
COD LIVER OILBBL281NWFGIACT

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
Skin Protectant for Babies and kidsSKIN PROTECTANT OINTMENTNeilmed Pharmaceuticals Inc.448b70db-ca81-db7b-e063-6294a90a5f0d2026-01-02WarningsExact identifier
ndc (package): 13709-352-01
ndc (product): 13709-352
ndc11 (package): 13709035201
spl id: 448b70db-ca82-db7b-e063-6294a90a5f0d
spl set id: 448b70db-ca81-db7b-e063-6294a90a5f0d

Reported adverse events (FAERS/openFDA)#

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