Search by Drug Name or NDC

NDC 49035-0965-98 Soothing Moisturizing 10.4 mg/g Details

Soothing Moisturizing 10.4 mg/g

Soothing Moisturizing is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc. The primary component is OATMEAL.

Product Information

NDC	49035-0965
Product ID	49035-965_43d4d54f-dac8-4b2b-82a3-81422fc15732
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	Soothing Moisturizing
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	Wal-Mart Stores, Inc
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 49035-0965-98 (49035096598)

Pricing Information	N/A
NDC Package Code	49035-965-98
Billing NDC	49035096598
Package	207 g in 1 TUBE (49035-965-98)
Marketing Start Date	2014-04-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2d813455-c268-4c6d-9952-eaf0e0007d90 Details

Active ingredient

Colloidal oatmeal 1 %

Purpose

Skin protectant

Uses

temporarily protectes 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

Questions?

1-888-287-1915

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Aveeno Active Naturals Eczema Therapy Moisturizing Cream

965.000/965AB

Distributed by:

Wal-Mart Stores, Inc.,

Bentonville, AR 72716

principal display panel

NDC 49035-965-98

equate beauty

Compare to Aveeno Active Naturals Eczema Therapy

ECZEMA SOOTHING MOISTURIZING CREAM

MOISTURIZE

Eczema Soothing Colloidal Oatmeal Skin Protectant

Soothes, dry, itchy & irritated skin resulting from eczema

FREE

PARABEN

STEROID

FRAGRANCE

NET WT 7.3 OZ (207 g)

INGREDIENTS AND APPEARANCE

SOOTHING MOISTURIZING

colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-965
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	Marketing End Date
Packaging
1	NDC:49035-965-98	207 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 - Wal-Mart Stores, Inc (051957769)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49035-965)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49035-965)

Revised: 9/2022

Document Id: 43d4d54f-dac8-4b2b-82a3-81422fc15732

Set id: 2d813455-c268-4c6d-9952-eaf0e0007d90

Version: 14

Effective Time: 20220929