OKEEFFES ECZEMA RELIEF BODY CREAM- colloidal oatmeal cream

OKeeffes Eczema Relief by

Drug Labeling and Warnings

OKeeffes Eczema Relief by is a Otc medication manufactured, distributed, or labeled by The Gorilla Glue Company/O'Keeffe's Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Colloidal oatmeal 2%

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

• rashes
• eczema

WARNINGS

Warnings

For external use only

WHEN USING

When using this product do not get into eyes

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

apply as needed

INACTIVE INGREDIENT

Inactive ingredients Water, Glycerin, Cetyl Alcohol, Isopropyl Myristate, Dimethicone, Aluminum Starch Octylsuccinate, Cetearyl Alcohol, Ceteareth-20, Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Distearyldimonium Chloride, Panthenol, Allantoin, 1,2-Hexanediol, Caprylyl Glycol, Polyquaternium-10, Beeswax, Caesalpinia Spinosa Gum, Bisabolol, Disodium EDTA, Zingiber Officianale (Ginger) Root Extract, Glyceryl Stearate, PEG-100 Stearate, Laureth-4, Laureth-23, Laureth-12, Phenoxyethanol, Ethylhexyglycerin

SPL UNCLASSIFIED SECTION

OKeeffesCompany.com

Questions/Comments: 1-800-275-2718

©2021 Distributed by:

O'Keeffe's Company

Cincinnati, OH 45241

Made in USA with Domestic and Imported Materials

PRINCIPAL DISPLAY PANEL

O'KEEFFE'S®

CLINICAL | BODY

ECZEMA RELIEF

BODY CREAM

48 HOUR ITCH RELIEF IN ONE USE

Colloidal Oatmeal Skin Protectant

Dermatologist Tested

Steroid & Fragrance Free

GUARANTEED RELIEF

for extremely dry, itchy, irritated skin

Net Wt. 8 oz. (227 g)

INGREDIENTS AND APPEARANCE

OKEEFFES ECZEMA RELIEF  BODY CREAM
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71564-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LAURETH-12 (UNII: OAH19558U1)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
YELLOW WAX (UNII: 2ZA36H0S2V)
PEG-100 STEARATE (UNII: YD01N1999R)
LAURETH-23 (UNII: N72LMW566G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GINGER (UNII: C5529G5JPQ)
SHEA BUTTER (UNII: K49155WL9Y)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PANTHENOL (UNII: WV9CM0O67Z)
LEVOMENOL (UNII: 24WE03BX2T)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-4 (UNII: 6HQ855798J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71564-004-08	227 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2020	10/17/2024
2	NDC: 71564-004-07	7 g in 1 TUBE; Type 0: Not a Combination Product	08/06/2020	05/27/2022
3	NDC: 71564-004-05	142 g in 1 TUBE; Type 0: Not a Combination Product	08/08/2022	03/23/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/01/2020	03/23/2025

Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)