Oatmeal Daily Moisturizing 8Oz. (Dimethicone) Lotion [China Ningbo Shangge Cosmetic Technology Corp.] -

OATMEAL DAILY MOISTURIZING 8OZ. (DIMETHICONE) LOTION [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]
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NDC	58503-107-01
Set ID	77e503e6-a794-0fda-e053-2991aa0a4ad7
Category	HUMAN OTC DRUG LABEL
Packager	China Ningbo Shangge Cosmetic Technology Corp.
Generic Name
Product Class
Product Number
Application Number	PART347

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ACTIVE INGREDIENT

Active Ingredient Purpose

Dimethicone 1.2% ......... 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
Uses
- Temporarily protects chafed, chapped or cracked skin
- Helps protect from the drying effects of cold weather and wind
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.

Do not use on
- Deep or puncture wounds
- Animal bites
- Serious burns
DOSAGE & ADMINISTRATION

Directions apply liberally as often as needed.
OTHER SAFETY INFORMATION

Other Information store at room temperature.

DISTRIBUTED BY:

MIDWOOD BRANDS, INC.

10611 MONROE,

MATTHEWS, NC 28105 USA

MADE IN CHINA
INACTIVE INGREDIENT

Inactive Ingredients

Water, Petrolatum, Benzyl Alcohol, Glycerin, Isopropyl Palmitate, Avena Sativa (Oat) Kernel Extract, Steraryl Alcohol, Distearyldimonium Chloride, Sodium Chloride
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OATMEAL DAILY MOISTURIZING 8OZ.
dimethicone lotion

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)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OAT KERNEL OIL (UNII: 3UVP41R77R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58503-107-01	227 g in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/10/2018

Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(58503-107)

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