OKEEFFES SKIN REPAIR BODY CREAM ECZEMA RELIEF- colloidal oatmeal cream

OKeeffes Skin Repair by

Drug Labeling and Warnings

OKeeffes Skin Repair 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
• poison ivy, oak, or sumac
• insect bites

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 Octenylsuccinate, Cetearyl Alcohol, Polysilicone-11, Ceteareth-20, Butyrospermum Parkii (Shea) Butter, Distearyldimonium Chloride, 1,2-Hexanediol, Allantoin, Caprylyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Caesalpinia Spinosa Gum, Panthenol, Polyquaternium-10, Beeswax, Bisabolol, Disodium EDTA, Laureth-12, Phenoxyethanol, Laureth-23, Laureth-4, Ethylhexylglycerin, Zingiber Offcinale Root Extract

SPL UNCLASSIFIED SECTION

OKeeffesCompany.com

Questions/Comments: 1-800-275-2718

©2025 Distributed by:

O'Keeffe's Company

Cincinnati, OH 45241

Made in USA with Domestic and Imported Materials

PRINCIPAL DISPLAY PANEL

O'KEEFFE'S®

SKIN REPAIR BODY CREAM

ECZEMA RELIEF

48 HOUR ITCH RELIEF IN ONE USE

Colloidal Oatmeal Skin Protectant

Dermatologist Approved

ACCEPTED National Eczema Association

Steroid & Fragrance Free

GUARANTEED RELIEF

Net Wt. 7 oz. (198 g)

INGREDIENTS AND APPEARANCE

OKEEFFES SKIN REPAIR  BODY CREAM ECZEMA RELIEF
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71564-010
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: 71564-010-98	198 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	09/01/2025

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