Colloidal oatmeal by H E B / Nice-Pak Products, LLC COLLOIDAL OATMEAL cream

Colloidal oatmeal by

Drug Labeling and Warnings

Colloidal oatmeal by is a Otc medication manufactured, distributed, or labeled by H E B, Nice-Pak Products, LLC. 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 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, isopropyl palmitate, cetyl alcohol, dimethicone, panthenol, Avena sativa (oat) kernel oil, steareth-20, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide

adverse reactions 

We hope you are satisfied with this product.  If not, we will cheerfully refund your money.

DISTRIBUTED BY: H-E-B ®, SAN ANTONIO, TX 78204

MADE IN THE USA WTH U.S. AND FOREIGN COMPONENTS

LOT NUMBER: ON PACKAGE

QUESTIONS OR COMMENTS? CALL TOLL FREE 1-888-593-0593

principal display panel

HILL COUNTRY™

ESSENTIALS

Baby Eczema

Therapy Cream

COLLOIDAL OATMEAL

SKIN PROTECTANT

FREE FROM

• parabens 
• phthalates 
• dyes

NET WT. 5 OZ CONT. NET. 141 g

PRINCIPAL DISPLAY PANEL

HILL COUNTRY FARE ®

Baby Eczema

Therapy Cream

COLLOIDAL OATMEAL 

SKIN PROTECTANT

FREE FROM

• parabens
• phthalates
• dyes

NET WT. 5 OZ CONT. NET. 141 g

INGREDIENTS AND APPEARANCE

COLLOIDAL OATMEAL 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 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)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
OAT KERNEL OIL (UNII: 3UVP41R77R)
STEARETH-20 (UNII: L0Q8IK9E08)
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: 37808-128-28	141 g in 1 TUBE; Type 0: Not a Combination Product	04/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/11/2019

Labeler - H E B (007924756)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(37808-128)