ECZEMA CARE MOISTURIZING 3 OZ.- colloidal oatmeal lotion
Rejoice International Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Eczema Care Moisturizing Cream 3 oz.

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

label

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Rejoice International Inc. (078741245)

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