Colloidal oatmeal by Amazon / Vi-Jon COLLOIDAL OATMEAL cream

Colloidal oatmeal by

Drug Labeling and Warnings

Colloidal oatmeal by is a Otc medication manufactured, distributed, or labeled by Amazon, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, panthenol, dimethicone, Avena sativa (oat) kernel oil, steareth-20, Avena sativa (oat) kernel extract, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide

Adverse reaction

DISTRIBUTED BY:

Amazon.com Services, Inc.

Seattle, WA 98109

1-877-485-0385

2018 Amazon.com, Inc. or its affilates.  All rights reserved.  Solimo and all related logos are trqademarks of Amazon.com. Inc. or its affiliates.

965.000/965AA

principal display panel

SOLIMO

Eczema

Soothing

Moisturizing

Cream

COLLOIDAL OATMEAL

SKIN PROTECTANT

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: 72288-965
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-965-98	207 g in 1 TUBE; Type 0: Not a Combination Product	04/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/25/2018

Labeler - Amazon (128990418)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(72288-965)