BABY ECZEMA THERAPY- colloidal oatmeal cream

Baby Eczema Therapy by

Drug Labeling and Warnings

Baby Eczema Therapy by is a Otc medication manufactured, distributed, or labeled by OLD EAST MAIN CO., Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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 within 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

Other information

store at room temperature

Inactive ingredients

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

disclaimer

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

Adverse Reactions

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction

Guaranteed!

(888)309-9030

601.000/601B

principal display panel

DG

baby

Baby Eczema

Therapy Cream

Colloidal Oatmeal

Skin Protectant

Compare to Aveeno Baby Eczema Therapy Moisturizing Cream

• Helps to reduce itching and irritation associated with eczema
• Steroid-free
• Fragrance Free

NET WT 5 OZ (141 g)

INGREDIENTS AND APPEARANCE

BABY ECZEMA THERAPY 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
oatmeal (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	oatmeal	10.4 kg  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)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CERAMIDE NP (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: 55910-803-28	141 g in 1 TUBE; Type 0: Not a Combination Product	04/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/11/2016

Labeler - DOLGENCORP, LLC (068331990)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55910-803)