XtraCare Oatmeal Daily Moisturizing Lotion Tube 8 oz

Manufacturer: Rejoice International Inc. | China Ningbo Shangge Technology Co., Ltd.
Effective date: 2025-02-13
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:55:24

Label at a glance#

ProductXtraCare Oatmeal Daily Moisturizing 8 oz

Active ingredientDIMETHICONE

Label structure9 sections

Storage and handling

Other information Store at room temperature.

Contacts and useful links#

PhoneLabel contact1-855-345-5575

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

OTC - QUESTIONS SECTION

Questions/comments? 1-855-345-5575

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
891710	dimethicone 1.3 % Topical Lotion	PSN	2
891710	dimethicone 13 MG/ML Topical Lotion	SCD	2
891710	dimethicone 1.3 % Topical Lotion	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-139-01	2025-02-13	C162847	48780-1	2cef2736-905a-d83d-e063-dadaa90ab31f	XtraCare Oatmeal Daily Moisturizing Lotion Tube 8 oz
57337-139-01	2025-01-30	C162847	48780-1	2cef2736-905a-d83d-e063-dadaa90ab31f	XtraCare Oatmeal Daily Moisturizing Lotion Tube 8 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-139-01	XtraCare Oatmeal Daily Moisturizing8 oz	227 g in 1 TUBE	LOTION	227		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-139	XTRACARE OATMEAL DAILY MOISTURIZING 8 OZ (DIMETHICONE) LOTION [REJOICE INTERNATIONAL INC.]	2	Current NDC, Legacy NDC, 1 package rows	20250216_c0670819-830e-4082-e053-2a95a90adadc.zip

Products#

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

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

XtraCare Oatmeal Daily Moisturizing 8 oz
Dimethicone
STEARYL ALCOHOL
METHYLPARABEN
GLYCERYL MONOSTEARATE
DMDM HYDANTOIN
PETROLATUM
OAT
PEG-100 STEARATE
WATER
GLYCERIN
EDETATE DISODIUM
POLYACRYLAMIDE (10000 MW)
C13-14 ISOPARAFFIN
ISOPROPYL MYRISTATE
PROPYLPARABEN
PROPYLENE GLYCOL
CETYL ALCOHOL
LAURETH-7

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57337-139	57337-139-01

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
Name	UNII	Kind
STEARYL ALCOHOL	2KR89I4H1Y	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
PETROLATUM	4T6H12BN9U	IACT
OAT	Z6J799EAJK	IACT
PEG-100 STEARATE	YD01N1999R	IACT
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
POLYACRYLAMIDE (10000 MW)	E2KR9C9V2I	IACT
C13-14 ISOPARAFFIN	E4F12ROE70	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CETYL ALCOHOL	936JST6JCN	IACT
LAURETH-7	Z95S6G8201	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XtraCare Oatmeal Daily Moisturizing 8 oz	DIMETHICONE	Rejoice International Inc.	c0670819-830e-4082-e053-2a95a90adadc	2025-02-13	Warnings	Exact identifier ndc (package): 57337-139-01 ndc (product): 57337-139 ndc11 (package): 57337013901 spl id: 2e12f061-7ef8-a13e-e063-6394a90a0a66 spl set id: c0670819-830e-4082-e053-2a95a90adadc

Reported adverse events (FAERS/openFDA)#

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