BABY XTRACARE OATMEAL- dimethicone lotion

Baby XtraCare Oatmeal by

Drug Labeling and Warnings

Baby XtraCare Oatmeal by is a Otc medication manufactured, distributed, or labeled by Rejoice International, China Ningbo Shangge Cosmetic Technology Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                      Purpose

Dimethicone 1.2% ............................ Skin Protectant

PURPOSE

Use

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Baby XtraCare®

Oatmeal Daily Moisturizing Lotion

Lightly Scented

Dimethicon Skin Protectant with Natural Oat Extract

Helps Soothe & Soften Baby's Skin

12 FL OZ (354 mL)

DOSAGE & ADMINISTRATION

Directions

Apply liberally as often as needed.

WARNINGS

Warnings

For extenal 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 7days or clear up and occur again within a few days.

INACTIVE INGREDIENT

Inactive Ingredients

water, petrolatum, mineral oil, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oatmeal) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben.

OTHER SAFETY INFORMATION

Other Information  Store at room temperature.

Questions/Comments? 1-855-345-5575

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 U.S.A.

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY XTRACARE OATMEAL 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
CETYL ALCOHOL (UNII: 936JST6JCN)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
DMDM HYDANTOIN (UNII: BYR0546TOW)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-070-01	227 g in 1 BOTTLE
2	NDC: 57337-070-02	354 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/16/2015

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-070)