XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING- dimethicone lotion
Rejoice International

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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XtraCare Skin Relief Oatmeal Daily Moisturizing

Active Ingredient Purpose

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

XtraCare Skin Relief Oatmeal Daily Moisturizing Lotion

dimethicone skin protectant

with soothing oat essence

To Protect & Relieve Dry Skin

12 fl oz (354 mL)

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

Use help prevent and temporarily protets chafed, chapped, or cracked skin.

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.

Directions apply liberally as often as needed.

Other information Store at room temperature.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

48325 BINGHAMPTON DR.,

NORTHVILLE, MI 48168 USA

MADE IN CHINA

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, methylparaben, propylparaben.

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XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57337-054
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3 g in 227 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
CETYL ALCOHOL (UNII: 936JST6JCN)
OAT (UNII: Z6J799EAJK)
DMDM HYDANTOIN (UNII: BYR0546TOW)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57337-054-01	227 g in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/26/2013

Labeler - Rejoice International (078741245)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-054)

Revised: 9/2019

Document Id: 92713898-b461-14f9-e053-2a95a90a5183

Set id: 5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907

Version: 2

Effective Time: 20190913

Rejoice International