FDA.reportPublic FDA data

FOOT CREAM

Manufacturer
Greenbrier International, Inc. | Lab Douce Cosmetics (Shenzhen) Co., Ltd.
Effective date
2020-12-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:03

Label at a glance#

ProductDIMETHICONE and PETROLATUM
Active ingredientPETROLATUM, DIMETHICONE
Label structure9 sections

Indications and uses

helps relieve, prevent and temporarily protect chafed, chapped or cracked skin

Dosage and administration

apply generously to affected area as needed Other information store at 20 o C-25 o C (68 o F to 77 o F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

White petrolatum 30%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps relieve, prevent and temporarily protect chafed, chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

For adult use only

Do not use on

  • ​deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness, irritation, swelling or pain persists or increases
  • symptoms persist for 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

  • apply generously to affected area as needed

Other information

  • store at 20 oC-25 oC (68 oF to 77 oF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, ammonium polyacrylate, glycerin, glyceryl stearate, cetearyl alcohol, triethanolamine, carbomer, panthenol, tocopheryl acetate, methylisothiazolinone

Distributed By

SPL UNCLASSIFIED SECTION

GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 MADE IN CHINA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diabetics' Foot Cream SKIN PROTECTANT NET WT. 4.5 OZ (128 g)

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cleanser LabelCleanser Label

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
33992-891833992-8918-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ALCOHOL936JST6JCNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PETROLATUM4T6H12BN9UACTIB
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML · Source PDF

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
b5c86fce-5e38-7017-e053-2995a90a1c497ff5abc0-e318-4081-e053-2991aa0afd3f2020-12-06WarningsExact identifier
spl id: b5c86fce-5e38-7017-e053-2995a90a1c49
spl set id: 7ff5abc0-e318-4081-e053-2991aa0afd3f

Reported adverse events (FAERS/openFDA)#

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