XTRACARE OATMEAL DAILY MOISTURIZING 8 OZ- dimethicone lotion

XtraCare Oatmeal Daily Moisturizing by

Drug Labeling and Warnings

XtraCare Oatmeal Daily Moisturizing by is a Otc medication manufactured, distributed, or labeled by Rejoice International Inc., China Ningbo Shangge Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Dimethicone 1.3%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

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

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions apply liberally as often as needed.

STORAGE AND HANDLING

Other information Store at room temperature.

INACTIVE INGREDIENT

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.

QUESTIONS

Questions/comments? 1-855-345-5575

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE OATMEAL DAILY MOISTURIZING  8 OZ
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.3 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-139-01	227 g in 1 TUBE; Type 0: Not a Combination Product	04/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/19/2021

Labeler - Rejoice International Inc. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Technology Co., Ltd.		529287434	manufacture(57337-139)