SKIN RELIEF OATMEAL DAILY MOISTURIZING- dimethicone lotion

Skin Relief Oatmeal Daily Moisturizing by

Drug Labeling and Warnings

Skin Relief Oatmeal Daily Moisturizing by is a Otc medication manufactured, distributed, or labeled by 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

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 protets 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 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: 

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

MADE IN CHINA

INACTIVE INGREDIENT

Inactive Ingredients water, petrolatum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oat) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, methylparaben, propylparaben.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN RELIEF OATMEAL DAILY MOISTURIZING 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58503-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58503-114-01	227 g in 1 TUBE; Type 0: Not a Combination Product	12/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/16/2018

Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(58503-114)