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NDC 00869-0965-98 Colloidal oatmeal 10.4 mg/g Details

Colloidal oatmeal 10.4 mg/g

Colloidal oatmeal is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Vi-Jon. The primary component is OATMEAL.

Product Information

NDC	00869-0965
Product ID	0869-0965_31334826-f01f-4c96-9ea9-a9ce345bab19
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	Colloidal oatmeal
Proprietary Name Suffix	n/a
Non-Proprietary Name	Colloidal oatmeal
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10.4
Active Ingredient Units	mg/g
Substance Name	OATMEAL
Labeler Name	Vi-Jon
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	2024-12-31

Package

Package Images

NDC 00869-0965-98 (00869096598)

Pricing Information	N/A
NDC Package Code	0869-0965-98
Billing NDC	00869096598
Package	207 g in 1 TUBE (0869-0965-98)
Marketing Start Date	2014-04-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b4fea140-a9b4-473c-afe9-42af7f8e907e Details

claims

eczema soothing

moisturizing

lotion

skin protectant

Active ingredient

Colloidal oatmeal 1%

Purpose

Skin protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

eczema
rashes

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again withing a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as needed

Inactive ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, pathenol, dimethicone, Avena sativa (oat) kernel oil, steareth-20, Avena sativa (oat) kernel extract, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide

principal display panel

mountain falls

*Compare to Aveeno

natural

colloidal

oatmeal

soothes dry, itchy, & irritated skin resulting from eczema

dermatologist tested

fragrace

free

eczema

soothing

moisturizing

lotion

skin protectant

NET WT 7.3 OZ (207 g)

PRINCIPAL DISPLAY PANEL

SIMPLY

ECZEMA

SOOTHING

MOSTURIZING

CREAM

COLLOIDAL OATMEAL

SKIN PROTECTANT

soothes dry, itchy &

irritated skin resulting

from eczema

steroid-free

fragrance free

Compare to Aveeno Active Naturals

Eczema Therapy Moisturizing Cream*

NET WT 7.3 OZ (207 g)

INGREDIENTS AND APPEARANCE

COLLOIDAL OATMEAL

colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0869-0965
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10.4 mg 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 KERNEL OIL (UNII: 3UVP41R77R)
STEARETH-20 (UNII: L0Q8IK9E08)
OAT (UNII: Z6J799EAJK)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CERAMIDE 3 (UNII: 4370DF050B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0869-0965-18	71 g in 1 TUBE; Type 0: Not a Combination Product	04/22/2014
2	NDC:0869-0965-98	207 g in 1 TUBE; Type 0: Not a Combination Product	04/22/2014
3	NDC:0869-0965-32	340 g in 1 TUBE; Type 0: Not a Combination Product	04/22/2014
4	NDC:0869-0965-44	510 g in 1 TUBE; Type 0: Not a Combination Product	04/22/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/22/2014

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(0869-0965)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		088520668	manufacture(0869-0965)

Revised: 5/2022

Document Id: 31334826-f01f-4c96-9ea9-a9ce345bab19

Set id: b4fea140-a9b4-473c-afe9-42af7f8e907e

Version: 14

Effective Time: 20220518