FDA.reportPublic FDA data

XtraCare Oatmeal Daily Moisturizing Lotion 8 oz

Manufacturer
China Ningbo Shangge Cosmetics Technology Corp. | China Ningbo Shangge Technology Co., Ltd.
Effective date
2021-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:50

Label at a glance#

ProductXtraCare Oatmeal Daily Moisturizing 8 oz
Active ingredientDIMETHICONE
Label structure9 sections

Storage and handling

Other information Store at room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Dimethicone 1.3%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

  • Help prevent and temporarily protects chafed, chapped, or cracked skin.

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contact, flush with water.

OTC - DO NOT USE SECTION

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions apply liberally as often as needed.

STORAGE AND HANDLING SECTION

Other information Store at room temperature.

INACTIVE INGREDIENT SECTION

Water, Petrolatum, Cetyl Alcohol, Glyceryl Stearate, Propylene Glycol, Glycerin, Stearyl Alcohol, PEG-100 Stearate, Polyacrylamide, DMDM Hydantoin, Isopropyl Myristate, Fragrance, C13-14 Isoparaffin, Laureth-7, Avena Sativa (Oat) Kernel Extract, Disodium, EDTA, Methylparaben, Propylparaben.

OTC - QUESTIONS SECTION

Questions/comments? 1-855-345-5575

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle LabelBottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891710dimethicone 1.3 % Topical LotionPSN1
891710dimethicone 13 MG/ML Topical LotionSCD1
891710dimethicone 1.3 % Topical LotionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-166-012024-01-30C16284748780-11030e365-4bda-111a-e063-dadaa90a10e2XtraCare Oatmeal Daily Moisturizing Lotion 8 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-166-01XtraCare Oatmeal Daily Moisturizing8 oz227 g in 1 BOTTLE, PUMPLOTION2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-166XTRACARE OATMEAL DAILY MOISTURIZING 8 OZ (DIMETHICONE) LOTION [CHINA NINGBO SHANGGE COSMETICS TECHNOLOGY CORP.]1Legacy NDC, 1 package rows20210421_c06dec02-a41c-39ae-e053-2995a90aa728.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58503-16658503-166-01

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
STEARYL ALCOHOL2KR89I4H1YIACT
METHYLPARABENA2I8C7HI9TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DMDM HYDANTOINBYR0546TOWIACT
PETROLATUM4T6H12BN9UIACT
OATZ6J799EAJKIACT
PEG-100 STEARATEYD01N1999RIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETYL ALCOHOL936JST6JCNIACT
LAURETH-7Z95S6G8201IACT
DIMETHICONE92RU3N3Y1OACTIB

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
c06dce1f-ea30-4937-e053-2a95a90ae780c06dec02-a41c-39ae-e053-2995a90aa7282021-04-20WarningsExact identifier
spl id: c06dce1f-ea30-4937-e053-2a95a90ae780
spl set id: c06dec02-a41c-39ae-e053-2995a90aa728

Reported adverse events (FAERS/openFDA)#

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