O'KEEFFE'S ECZEMA RELIEF BODY CREAM

Drug Details [pdf]

OKEEFFES ECZEMA RELIEF BODY CREAM- colloidal oatmeal cream
The Gorilla Glue Company/O'Keeffe's Company

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O'KEEFFE'S ECZEMA RELIEF BODY CREAM

Drug Facts

Active ingredient

Colloidal oatmeal 2%

Purpose

Skin protectant

Uses

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

rashes
eczema

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

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

OKeeffesCompany.com

Questions/Comments: 1-800-275-2718

O'Keeffe's Company

Cincinnati, OH 45241

Made in USA with Domestic and Imported Materials

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)

71564-004 ECZEMA RELIEF 01-2022

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	07/01/2020	03/23/2025

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

Revised: 1/2025

Document Id: 2ddee3cf-65d9-0f5d-e063-6294a90a5fcd

Set id: a9c957f7-bbfe-2369-e053-2995a90a0b06

Version: 6

Effective Time: 20250101

The

O'KEEFFE'S ECZEMA RELIEF BODY CREAM

OKeeffes Eczema Relief by

Drug Labeling and Warnings

Drug Details [pdf]

O'KEEFFE'S ECZEMA RELIEF BODY CREAM