XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN- dimethicone lotion

XtraCare with cooling action Oatmeal Skin Relief Calmin by

Drug Labeling and Warnings

XtraCare with cooling action Oatmeal Skin Relief Calmin 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 1/3% ......... Skin Protectant

PURPOSE

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)

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

Use 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.

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

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 mg  in 354 mg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
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)
MENTHOL (UNII: L7T10EIP3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-038-01	354 mg in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2013
2	NDC: 57337-038-02	227 mg in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2013

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

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(57337-038)