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NDC 59779-0355-12 Eczema Care 10 mg/mL Details

Eczema Care 10 mg/mL

Eczema Care is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is OATMEAL.

Product Information

NDC	59779-0355
Product ID	59779-355_f5fa36cb-a274-487e-8e19-6fa3119fd761
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Eczema Care
Proprietary Name Suffix	n/a
Non-Proprietary Name	Colloidal Oatmeal
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	OATMEAL
Labeler Name	CVS Pharmacy
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2022-12-31

Package

Package Images

NDC 59779-0355-12 (59779035512)

Pricing Information	N/A
NDC Package Code	59779-355-12
Billing NDC	59779035512
Package	354 mL in 1 BOTTLE, PLASTIC (59779-355-12)
Marketing Start Date	2012-12-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b7e688a3-0f74-4134-a1c5-68a8575e62c8 Details

Active ingredient

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin itching and irritation due to eczema.

Warnings

For external use only.

When using this product

avoid contact with eyes.
if contact occurs, rinse thoroughly 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

for mild to moderate eczema only, apply as needed or as directed by a physician.

Other information

store at room temperature.

Inactive ingredients

Water (Aqua), Glycerin, Distearyldimonium Chloride, Panthenol, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Avena Sativa (Oat) Kernel Extract, Benzalkonium Chloride, Isocetyl Alcohol, Ceramide NP, Sodium Chloride.

Label copy

INGREDIENTS AND APPEARANCE

ECZEMA CARE

colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-355
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 PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
OAT KERNEL OIL (UNII: 3UVP41R77R)
STEARETH-20 (UNII: L0Q8IK9E08)
OAT (UNII: Z6J799EAJK)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
ISOCETYL ALCOHOL (UNII: 1800H64066)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-355-07	216 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/28/2017

Labeler - CVS Pharmacy (062312574)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(59779-355)

Revised: 9/2017

Document Id: f5fa36cb-a274-487e-8e19-6fa3119fd761

Set id: b7e688a3-0f74-4134-a1c5-68a8575e62c8

Version: 1

Effective Time: 20170905