Colloidal oatmeal by Vi-Jon / Vi-Jon, LLC COLLOIDAL OATMEAL cream

Colloidal oatmeal by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

U

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

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

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

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