ECZEMA CARE MOISTURIZING 3 OZ.- colloidal oatmeal lotion

Eczema Care Moisturizing by

Drug Labeling and Warnings

Eczema Care Moisturizing by is a Otc medication manufactured, distributed, or labeled by Rejoice International Inc., China Ningbo Shangge Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

• Temporarily protects and helps relieve minor skin itching and irritation due to:
• Eczema
• Rashes

Warnings

For external use only.

When using this product

• avoid contact with eyes. In case of eye contact, flush with water.

Stop using this product and ask a doctor if

• condition worsens, or if symptoms last more than 7 days, or if they clear up and occur again within a few days.

Keep out of reach of children.

• In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Apply as needed

Other information

• store at room temperature.

Inactive ingredients

Water, Glycerin, Petrolatum, Cetearyl Alcohol, Dimethicone, Isopropyl Myristate, Distearyldimonium Chloride, Steareth-2, Avena Sativa (Oat) Kernel Extract, Phenoxyethanol, Steareth-21, Sodium Chloride, Benzalkonium Chloride, Panthenol, Ceramide NP, Avena Sativa (Oat) Kernel Oil

Label copy

INGREDIENTS AND APPEARANCE

ECZEMA CARE MOISTURIZING  3 OZ.
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PANTHENOL (UNII: WV9CM0O67Z)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
OAT KERNEL OIL (UNII: 3UVP41R77R)
STEARETH-20 (UNII: L0Q8IK9E08)
OAT (UNII: Z6J799EAJK)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARETH-2 (UNII: V56DFE46J5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-101-01	85 mL in 1 TUBE; Type 0: Not a Combination Product	03/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/08/2019

Labeler - Rejoice International Inc. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Technology Co., Ltd.		529287434	manufacture(57337-101)