FDA.reportPublic FDA data

770 Sensi-Care Body Cream

Manufacturer
Medline Industries, LP
Effective date
2024-07-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:59:43

Label at a glance#

ProductSensi-Care
Active ingredientDIMETHICONE, PETROLATUM
Label structure8 sections

Indications and uses

temporarily protects minor cuts, scrapes, burns 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 and helps seal out wetness

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1% w/w

White petrolatum 30% w/w

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects minor cuts, scrapes, burns
  • 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 and 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 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 consult 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, cleanse the diaper area, and allow to dry
  • apply cream liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diaper may be prolonged

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, cetyl alcohol, diazolidinyl urea, glycerin, laureth-23, magnesium, magnesium aluminum silicate, magnesium chloride, methylchloroisothiazolinone, methylisothiazolinone, nitrate, propylene glycol diethylhexanoate, pvp/hexadecene copolymer, sodium hydroxide, steareth-2, water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of foreign and domestic materials

www.medline.com

1-800-MEDLINE

REF: 324403

V1 RE21GSG

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-770-792023-08-08C16284748780-10191ceaa-6431-198a-e063-dbdaa90aec3e770 Sensi-Care Body Cream
53329-770-792023-07-28C16284748780-10191ceaa-6431-198a-e063-dbdaa90aec3e770 Sensi-Care Body Cream

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-77053329-770-79

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
DIMETHICONE92RU3N3Y1OACTIB
PETROLATUM4T6H12BN9UACTIB
HEXADECENE (MIXED ISOMERS)38H8547VP0IACT
STEARETH-2V56DFE46J5IACT
WATER059QF0KO0RIACT
MAGNESIUMI38ZP9992AIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
NITRATE IONT93E9Y2844IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
LAURETH-23N72LMW566GIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PROPYLENE GLYCOL DIETHYLHEXANOATE8D8I9Z0F1ZIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
1c480c5b-381f-6e5e-e063-6394a90a6fc1af5fbed1-b639-66d4-e053-2a95a90a30262024-07-02WarningsExact identifier
spl id: 1c480c5b-381f-6e5e-e063-6394a90a6fc1
spl set id: af5fbed1-b639-66d4-e053-2a95a90a3026

Reported adverse events (FAERS/openFDA)#

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