OATMEAL SKIN RELIEF CALMING . 8OZ- dimethicone lotion

Oatmeal Skin Relief Calming . by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Dimethicone 1.3%

PURPOSE

Purpose

Skin protectant

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.

Do not use on

Deep or puncture wounds
Animal bites
Serious burns

Stop use and ask a doctor if conditions 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.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Petrolatum, Cetyl Alcohol, Glyceryl Stearate, Propylene Glycol, Glycerin, Stearyl Alcohol, PEG-100 Stearate, Polyacrylamide, DMDM Hydrantoin, Isopropyl Myristate, Fragrance, C13-14 Isoparaffin, Laureth-7, Avena Sativa (Oat) Kernel Extract, Disodium EDTA, Methylparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OATMEAL SKIN RELIEF CALMING .  8OZ
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-100
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETYL STEARATE (UNII: 06RI5UQA7L)
PEG-100 STEARATE (UNII: YD01N1999R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
OAT KERNEL OIL (UNII: 3UVP41R77R)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-100-01	227 g in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/07/2019

Labeler - Rejoice International Inc. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(57337-100)