XtraCare with cooling action Oatmeal Skin Relief Calmin

Manufacturer: China Ningbo Shangge Cosmetic Technology Corp.
Effective date: 2019-09-13
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:00:23

Label at a glance#

ProductXtraCare with cooling action Oatmeal Skin Relief Calmin

Active ingredientDIMETHICONE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Dimethicone 1/3% ......... Skin Protectant

OTC - PURPOSE SECTION

XtraCare (with cooling action) Oatmeal Skin Relief Calming Lotion

dimethicone skin protectant

with natural colloidal oatmeal

provides immediate and lasting moisture relief for itchy, extra dry skin

12 fl oz (354 mL)

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.

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings For external use only.

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions apply liberally as often as needed.

OTHER SAFETY INFORMATION

Other Information store at room temperature.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

48325 BINGHAMPTON DR.,

NORTHVILLE, MI 48168 USA

MADE IN CHINA

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, menthol, aloe barbadensis leaf juice, methylparaben, propylparaben.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label image

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
58503-055-01	2024-01-30	C162847	48780-1	1030e365-50bc-111a-e063-dadaa90a10e2	XtraCare with cooling action Oatmeal Skin Relief Calmin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58503-055-01	XtraCare with cooling action Oatmeal Skin Relief Calmin	227 g in 1 BOTTLE	LOTION	227		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58503-055	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2	Legacy NDC, 1 package rows	20190914_a6dfaef5-8e98-4575-9f46-1e27e28fbac0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
OAT	INACTIVE INGREDIENT	Z6J799EAJK	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
POLYACRYLAMIDE (1500 MW)	INACTIVE INGREDIENT	5D6TC4BRWV	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

XtraCare with cooling action Oatmeal Skin Relief Calmin
Dimethicone
WATER
MINERAL OIL
PETROLATUM
GLYCERIN
GLYCERYL MONOSTEARATE
PROPYLENE GLYCOL
PEG-100 STEARATE
POLYACRYLAMIDE (1500 MW)
CETYL ALCOHOL
OAT
DMDM HYDANTOIN
STEARYL ALCOHOL
C13-14 ISOPARAFFIN
LAURETH-7
EDETATE DISODIUM
MENTHOL
ALOE VERA LEAF
METHYLPARABEN
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58503-055	58503-055-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PEG-100 STEARATE	YD01N1999R	IACT
POLYACRYLAMIDE (1500 MW)	5D6TC4BRWV	IACT
CETYL ALCOHOL	936JST6JCN	IACT
OAT	Z6J799EAJK	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
C13-14 ISOPARAFFIN	E4F12ROE70	IACT
LAURETH-7	Z95S6G8201	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
MENTHOL	L7T10EIP3A	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 509 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	TABLET, EXTENDED RELEASE / ORAL	244 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	MOUTHWASH / BUCCAL	0.15 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates

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
927035cb-87cc-d33c-e053-2a95a90a39b4			a6dfaef5-8e98-4575-9f46-1e27e28fbac0	2019-09-13	Warnings	Exact identifier spl id: 927035cb-87cc-d33c-e053-2a95a90a39b4 spl set id: a6dfaef5-8e98-4575-9f46-1e27e28fbac0

Reported adverse events (FAERS/openFDA)#

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