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NDC 00363-3550-05 Walgreens Baby Eczema 0.01 g/g Details

Walgreens Baby Eczema 0.01 g/g

Walgreens Baby Eczema is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is OATMEAL.

Product Information

NDC	00363-3550
Product ID	0363-3550_7e98794d-170f-400a-acb7-8c9ab35c8e77
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	Walgreens Baby Eczema
Proprietary Name Suffix	n/a
Non-Proprietary Name	Colloidal Oatmeal
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.01
Active Ingredient Units	g/g
Substance Name	OATMEAL
Labeler Name	Walgreen Company
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 00363-3550-05 (00363355005)

Pricing Information	N/A
NDC Package Code	0363-3550-05
Billing NDC	00363355005
Package	142 g in 1 TUBE (0363-3550-05)
Marketing Start Date	2017-11-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4138eb24-bef2-49df-ad9c-ab6c5d381baa 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

apply as needed or as directed by a physician.

Other information

store at room temperature

Inactive ingredients

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

Questions or comments?

1-800-925-4733

Label Copy

INGREDIENTS AND APPEARANCE

WALGREENS BABY ECZEMA

colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-3550
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.01 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
PANTHENOL (UNII: WV9CM0O67Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
OAT (UNII: Z6J799EAJK)
STEARETH-20 (UNII: L0Q8IK9E08)
OAT KERNEL OIL (UNII: 3UVP41R77R)
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:0363-3550-05	142 g in 1 TUBE; Type 0: Not a Combination Product	11/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/28/2017

Labeler - Walgreen Company (008965063)

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

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(0363-3550)

Revised: 11/2017

Document Id: 7e98794d-170f-400a-acb7-8c9ab35c8e77

Set id: 4138eb24-bef2-49df-ad9c-ab6c5d381baa

Version: 1

Effective Time: 20171129