OATMEAL- dimethicone lotion

Oatmeal by

Drug Labeling and Warnings

Oatmeal by is a Otc medication manufactured, distributed, or labeled by GREENBRIER INTERNATIONAL, NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                          Purpose

Dimethicone 0.15%                                      Skin Protectant

PURPOSE

Help prevent and temporarily protects chafed, chapped or cracked skin.
Helps prevent and protect from the drying effects of wind and cold weather.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Apply as needed, and do not get into eyes.

WARNINGS

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

apply as needed

INACTIVE INGREDIENT

water, mineral oil, cetyl alcohol, glycerin, propylene glycol, methylparaben, propylparaben, DMDM hydantoin, steareth-30, ammonium polyacrylate,  C13-16 isoparaffin, glyceryl stearate, fragrance, avena sativa (oat) protein extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OATMEAL 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-1129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O)	dimethicone	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
mineral oil (UNII: T5L8T28FGP)
cetyl alcohol (UNII: 936JST6JCN)
petrolatum (UNII: 4T6H12BN9U)
glycerin (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
dmdm hydantoin (UNII: BYR0546TOW)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)
steareth-30 (UNII: 5776GCL1DG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-1129-1	340.2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/06/2011

Labeler - GREENBRIER INTERNATIONAL (610322518)

Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.		529047265	manufacture