FDA.reportPublic FDA data

Sensi-Care

Manufacturer
Medline Industries, LP
Effective date
2024-07-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:14:41

Label at a glance#

ProductSensi-Care
Active ingredientZINC OXIDE, PETROLATUM
Label structure9 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked skin and lips helps treat and prevent diaper rash protects minor skin irritation associated with diaper rash adn helps seal out wetness

Dosage and administration

for skin protection: apply as needed for diaper rash: change wet and soiled diapers promptly, cleans the diaper area, and allow to dry apply liberally, as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

White petrolatum 49% w/w

Zinc oxide 15% w/w

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked skin and lips
  • helps treat and prevent diaper rash
  • protects minor skin irritation associated with diaper rash adn helps seal out wetness

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

do not get in eyes

Stop use and ask 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

for skin protection:

  • apply as needed

for diaper rash:

  • change wet and soiled diapers promptly, cleans the diaper area, and allow to dry
  • apply liberally, as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

OTHER SAFETY INFORMATION

  • store at 15°C-30°C (59°F-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, cetyl dimethicone copolyol, glycerin, hexyl laurate, phenoxyethanol, polyglyceryl-4 isostearate, stearic acid, water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with foreign and domestic materials

www.medline.com

1-800-MEDLINE

REF: 325614

V1 RE21AXQ

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-771SENSI-CARE (PETROLATUM, ZINC OXIDE) CREAM [MEDLINE INDUSTRIES, LP]5Legacy NDC20240704_af5f9d80-9697-edfd-e053-2a95a90a32b4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-771-44GM - Gram53329-77110d45f00-1076-4013-bb76-90aa1b9cab6612023-04-07

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-77153329-771-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
PETROLATUM4T6H12BN9UACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
STEARIC ACID4ELV7Z65APIACT

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
1c483e5a-29d3-a10e-e063-6394a90a98a9af5f9d80-9697-edfd-e053-2a95a90a32b42024-07-02WarningsExact identifier
spl id: 1c483e5a-29d3-a10e-e063-6394a90a98a9
spl set id: af5f9d80-9697-edfd-e053-2a95a90a32b4

Reported adverse events (FAERS/openFDA)#

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